Z-0176-2027 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-0176-2027 was initiated by Medline Industries, LP on Sep 2, 2026 and is designated Class II. Reason for recall: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. The recall status is ongoing. Affected quantity: 36199 kits.

Recall Details

Product Type
Devices
Report Date
Oct 21, 2026
Initiation Date
Sep 2, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36199 kits

Product Description

Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product number/SKU DYNJ53741N; 5) OPEN HEART PACK 1&2, Medline Product number/SKU DYNJ80701A; 6) VEIN PACK, Medline Product number/SKU DYNJ67308C; 7) OPEN HEART PACK, Medline Product number/SKU DYNJ89451B; 8) VASCULAR TRAY-LF, Medline Product number/SKU DYNJ42166A; 9) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363C; 10) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363B; 11) LIVER TRANSPLANT PACK B, Medline Product number/SKU DYNJ65779B; 12) CABG PACK-LF, Medline Product number/SKU DYNJ47661J; 13) VEIN HARVEST PACK, Medline Product number/SKU DYNJ04470L; 14) CARDIAC PACK, Medline Product number/SKU DYNJ44647D; 15) GM OPEN HEART ACC PACK-LF, Medline Product number/SKU DYNJ0660029AM; 16) CARDIOVASCULAR PACK-LF, Medline Product number/SKU DYNJ0160327C; 17) GOOD SHEPHERD OPEN HEART, Medline Product number/SKU DYNJ60819L; 18) OPEN HEART PACK, Medline Product number/SKU DYNJ0271227R; 19) OPEN HEART PACK, Medline Product number/SKU DYNJ81541C; 20) TAVR PACK, Medline Product number/SKU DYNJ54094F; 21) TRANSPLANT BACKTABLE PACK, Medline Product number/SKU DYNJ62055C; 22) VASCULAR, Medline Product number/SKU DYNJ49366; 23) BACK TABLE TRAY, Medline Product number/SKU DYNJ65416D; 24) CV PART 1 AND 2, Medline Product number/SKU DYNJ908879G; 25) OPEN HEART A B PACK, Medline Product number/SKU DYNJ81096B; 26) KIDNEY, Medline Product number/SKU DYNJ54732I; 27) ABDOMINAL PRESEVERVATION PACK, Medline Product number/SKU DYNJ62691F; 28) LIVER PACK SAFETY, Medline Product number/SKU DYNJ54734I; 29) CV PROCEDURE PART A, Medline Product number/SKU DYNJ903745I;

Reason for Recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Distribution Pattern

US Nationwide distribution.

Code Information

Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 26DMA968; Medline product number/SKU DYNJT5715A, UDI/DI 10198459505126 (each) 40198459505127 (case), Lot number 26CMI506; Medline product number/SKU DYNJ85751, UDI/DI 10195327542917 (each) 40195327542918 (case), Lot number 26BMB785; Medline product number/SKU DYNJ53741N, UDI/DI 10198459560088 (each) 40198459560089 (case), Lot number 26BBG793; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 26BBF945; Medline product number/SKU DYNJ67308C, UDI/DI 10198459676666 (each) 40198459676667 (case), Lot number 26BBF661; Medline product number/SKU DYNJ89451B, UDI/DI 10198459637674 (each) 40198459637675 (case), Lot number 26BBC903; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 26BBB320; Medline product number/SKU DYNJ67363C, UDI/DI 10198459652226 (each) 40198459652227 (case), Lot number 26AML066; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 26AMK067; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 26AMI446; Medline product number/SKU DYNJ47661J, UDI/DI 10198459525704 (each) 40198459525705 (case), Lot number 26AMF686; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 26AMF245; Medline product number/SKU DYNJ04470L, UDI/DI 10198459548031 (each) 40198459548032 (case), Lot number 26AME079; Medline product number/SKU DYNJ44647D, UDI/DI 10198459615085 (each) 40198459615086 (case), Lot number 26AMC530; Medline product number/SKU DYNJ0660029AM, UDI/DI 10198459486296 (each) 40198459486297 (case), Lot number 26AMA935; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 26ADA892; Medline product number/SKU DYNJ60819L, UDI/DI 10198459536113 (each) 40198459536114 (case), Lot number 26ABW172; Medline product number/SKU DYNJ0271227R, UDI/DI 10198459591846 (each) 40198459591847 (case), Lot number 26ABU969; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 26ABS893; Medline product number/SKU DYNJ54094F, UDI/DI 10198459286247 (each) 40198459286248 (case), Lot number 26ABR346; Medline product number/SKU DYNJ62055C, UDI/DI 10198459591914 (each) 40198459591915 (case), Lot number 26ABQ526; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 26ABQ367; Medline product number/SKU DYNJ65416D, UDI/DI 10198459117404 (each) 40198459117405 (case), Lot number 26ABO155; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 26ABN783; Medline product number/SKU DYNJ81096B, UDI/DI 10195327590673 (each) 40195327590674 (case), Lot number 26ABM969; Medline product number/SKU DYNJ53741N, UDI/DI 10198459560088 (each) 40198459560089 (case), Lot number 26ABM155; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 26ABK432; Medline product number/SKU DYNJ62691F, UDI/DI 10198459501364 (each) 40198459501365 (case), Lot number 26ABK423; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 26ABI561; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 26ABG526; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 26ABD862; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 26ABC126; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 26ABB509; Medline product number/SKU DYNJ82955C, UDI/DI 10198459496141 (each) 40198459496142 (case), Lot number 25LMH836; Medline product number/SKU DYNJ0199156Y, UDI/DI 10198459570674 (each) 40198459570675 (case), Lot number 25LMF125; Medline product number/SKU DYNJ04470L, UDI/DI 10198459548031 (each) 40198459548032 (case), Lot number 25LMD727; Medline product number/SKU DYNJ20431M, UDI/DI 10198459575372 (each) 40198459575373 (case), Lot number 25LLA663; Medline product number/SKU DYNJ51804J, UDI/DI 10198459507854 (each) 40198459507855 (case), Lot number 25LDB738; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 25LBU940; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25LBU586; Medline product number/SKU DYNJ41230K, UDI/DI 10193489675634 (each) 40193489675635 (case), Lot number 25LBT794; Medline product number/SKU DYNJ67178G, UDI/DI 10198459523052 (each) 40198459523053 (case), Lot number 25LBQ135; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 25LBL953; Medline product number/SKU DYNJ87331B, UDI/DI 10198459205309 (each) 40198459205300 (case), Lot number 25LBL876; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25LBL568; Medline product number/SKU DYNJ48310J, UDI/DI 10198459426292 (each) 40198459426293 (case), Lot number 25LBL187; Medline product number/SKU DYNJ80520C, UDI/DI 10198459389733 (each) 40198459389734 (case), Lot number 25LBK401; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25LBI505; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 25LBA956; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25LBA067; Medline product number/SKU DYNJ85751, UDI/DI 10195327542917 (each) 40195327542918 (case), Lot number 25KMI931; Medline product number/SKU DYNJ0567824AB, UDI/DI 10198459569661 (each) 40198459569662 (case), Lot number 25KMF855; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 25KME463; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 25KDB251; Medline product number/SKU DYNJ89451A, UDI/DI 10198459484858 (each) 40198459484859 (case), Lot number 25KBT368; Medline product number/SKU DYNJ0541930P, UDI/DI 10198459293894 (each) 40198459293895 (case), Lot number 25KBR421; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25KBR317; Medline product number/SKU DYNJ31285J, UDI/DI 10198459107023 (each) 40198459107024 (case), Lot number 25KBQ727; Medline product number/SKU DYNJ40396C, UDI/DI 10198459047275 (each) 40198459047276 (case), Lot number 25KBQ480; Medline product number/SKU DYNJ62691F, UDI/DI 10198459501364 (each) 40198459501365 (case), Lot number 25KBQ454; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25KBM369; Medline product number/SKU DYNJ65416D, UDI/DI 10198459117404 (each) 40198459117405 (case), Lot number 25KBL324; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 25KBL141; Medline product number/SKU DYNJ31902O, UDI/DI 10195327691226 (each) 40195327691227 (case), Lot number 25KBK250; Medline product number/SKU DYNJ60819L, UDI/DI 10198459536113 (each) 40198459536114 (case), Lot number 25KBK234; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25KBJ473; Medline product number/SKU DYNJ62055C, UDI/DI 10198459591914 (each) 40198459591915 (case), Lot number 25KBJ303; Medline product number/SKU DYNJ80520C, UDI/DI 10198459389733 (each) 40198459389734 (case), Lot number 25KBI775; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25KBI770; Medline product number/SKU DYNJ53927N, UDI/DI 10198459426322 (each) 40198459426323 (case), Lot number 25KBI285; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25KBH205; Medline product number/SKU DYNJ62691F, UDI/DI 10198459501364 (each) 40198459501365 (case), Lot number 25KBF456; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25KBE458; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 25KBC314; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 25JMJ503; Medline product number/SKU DYNJ0660029AM, UDI/DI 10198459486296 (each) 40198459486297 (case), Lot number 25JMH944; Medline product number/SKU CVT097AF, UDI/DI 10198459465789 (each) 40198459465780 (case), Lot number 25JMH755; Medline product number/SKU DYNJ51804J, UDI/DI 10198459507854 (each) 40198459507855 (case), Lot number 25JDA522; Medline product number/SKU DYNJ40396C, UDI/DI 10198459047275 (each) 40198459047276 (case), Lot number 25JBW419; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 25JBV598; Medline product number/SKU DYNJ53741N, UDI/DI 10198459560088 (each) 40198459560089 (case), Lot number 25JBV307; Medline product number/SKU DYNJ52036G, UDI/DI 10195327663254 (each) 40195327663255 (case), Lot number 25JBV081; Medline product number/SKU DYNJ55974D, UDI/DI 10198459396991 (each) 40198459396992 (case), Lot number 25JBT781; Medline product number/SKU DYNJ85782, UDI/DI 10195327548605 (each) 40195327548606 (case), Lot number 25JBT773; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25JBS497; Medline product number/SKU DYNJ62691F, UDI/DI 10198459501364 (each) 40198459501365 (case), Lot number 25JBS149; Medline product number/SKU DYNJ87331B, UDI/DI 10198459205309 (each) 40198459205300 (case), Lot number 25JBS085; Medline product number/SKU DYNJ42920C, UDI/DI 10195327649005 (each) 40195327649006 (case), Lot number 25JBQ300; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25JBO751; Medline product number/SKU DYNJ81096B, UDI/DI 10195327590673 (each) 40195327590674 (case), Lot number 25JBO397; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25JBN942; Medline product number/SKU DYNJ0408782AC, UDI/DI 10198459335945 (each) 40198459335946 (case), Lot number 25JBM427; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25JBI757; Medline product number/SKU DYNJ53927N, UDI/DI 10198459426322 (each) 40198459426323 (case), Lot number 25JBH640; Medline product number/SKU DYNJ80520C, UDI/DI 10198459389733 (each) 40198459389734 (case), Lot number 25JBG534; Medline product number/SKU DYNJ17449N, UDI/DI 10195327692940 (each) 40195327692941 (case), Lot number 25JBG280; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25JBF072; Medline product number/SKU DYNJ67178G, UDI/DI 10198459523052 (each) 40198459523053 (case), Lot number 25JBE686; Medline product number/SKU DYNJ52921B, UDI/DI 10889942739240 (each) 40889942739241 (case), Lot number 25JBB049; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 25JBB023; Medline product number/SKU DYNJ62691F, UDI/DI 10198459501364 (each) 40198459501365 (case), Lot number 25JBA885; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 25IMI401; Medline product number/SKU DYNJ04478S, UDI/DI 10198459225987 (each) 40198459225988 (case), Lot number 25IMH396; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 25IMH167; Medline product number/SKU DYNJ0199156X, UDI/DI 10198459516917 (each) 40198459516918 (case), Lot number 25IMH024; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 25IME480; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 25IMD251; Medline product number/SKU DYNJT5715A, UDI/DI 10198459505126 (each) 40198459505127 (case), Lot number 25IMD157; Medline product number/SKU DYNJ47661J, UDI/DI 10198459525704 (each) 40198459525705 (case), Lot number 25IMC737; Medline product number/SKU DYNJT5715A, UDI/DI 10198459505126 (each) 40198459505127 (case), Lot number 25IMB472; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 25IDB879; Medline product number/SKU DYNJ904678K, UDI/DI 10198459375842 (each) 40198459375843 (case), Lot number 25IDB735; Medline product number/SKU DYNJ904678K, UDI/DI 10198459375842 (each) 40198459375843 (case), Lot number 25IDB136; Medline product number/SKU DYNJ0271227Q, UDI/DI 10195327589455 (each) 40195327589456 (case), Lot number 25IBS689; Medline product number/SKU DYNJ0541930P, UDI/DI 10198459293894 (each) 40198459293895 (case), Lot number 25IBS443; Medline product number/SKU DYNJ89451A, UDI/DI 10198459484858 (each) 40198459484859 (case), Lot number 25IBR913; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25IBP079; Medline product number/SKU DYNJ67142G, UDI/DI 10198459295065 (each) 40198459295066 (case), Lot number 25IBM742; Medline product number/SKU DYNJ31285J, UDI/DI 10198459107023 (each) 40198459107024 (case), Lot number 25IBL254; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 25IBK545; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25IBJ889; Medline product number/SKU DYNJ81096B, UDI/DI 10195327590673 (each) 40195327590674 (case), Lot number 25IBI137; Medline product number/SKU DYNJ54094F, UDI/DI 10198459286247 (each) 40198459286248 (case), Lot number 25IBH422; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 25IBF961; Medline product number/SKU DYNJ87021B, UDI/DI 10198459239618 (each) 40198459239619 (case), Lot number 25IBF550; Medline product number/SKU DYNJ53121, UDI/DI 10884389434093 (each) 40884389434094 (case), Lot number 25HMI870; Medline product number/SKU DYNJ0660029AM, UDI/DI 10198459486296 (each) 40198459486297 (case), Lot number 25HMI858; Medline product number/SKU DYNJ63135D, UDI/DI 10198459372636 (each) 40198459372637 (case), Lot number 25HMH683; Medline product number/SKU DYNJ04478S, UDI/DI 10198459225987 (each) 40198459225988 (case), Lot number 25HMH580; Medline product number/SKU DYNJ04470K, UDI/DI 10198459468957 (each) 40198459468958 (case), Lot number 25HMF415; Medline product number/SKU DYNJ0199156W, UDI/DI 10198459376429 (each) 40198459376420 (case), Lot number 25HMC955; Medline product number/SKU DYNJ904678K, UDI/DI 10198459375842 (each) 40198459375843 (case), Lot number 25HDA846; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 25HDA572; Medline product number/SKU DYNJ904678K, UDI/DI 10198459375842 (each) 40198459375843 (case), Lot number 25HDA229; Medline product number/SKU DYNJ53927N, UDI/DI 10198459426322 (each) 40198459426323 (case), Lot number 25HBV806; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25HBU584; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 25HBU238; Medline product number/SKU DYNJ52036G, UDI/DI 10195327663254 (each) 40195327663255 (case), Lot number 25HBT902; Medline product number/SKU DYNJ911274A, UDI/DI 10198459424236 (each) 40198459424237 (case), Lot number 25HBS371; Medline product number/SKU DYNJ87021B, UDI/DI 10198459239618 (each) 40198459239619 (case), Lot number 25HBS169; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25HBS103; Medline product number/SKU DYNJ80520C, UDI/DI 10198459389733 (each) 40198459389734 (case), Lot number 25HBQ748; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 25HBP208; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 25HBO679; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25HBO190; Medline product number/SKU DYNJ40396C, UDI/DI 10198459047275 (each) 40198459047276 (case), Lot number 25HBO186; Medline product number/SKU DYNJ911274A, UDI/DI 10198459424236 (each) 40198459424237 (case), Lot number 25HBN571; Medline product number/SKU DYNJ52036G, UDI/DI 10195327663254 (each) 40195327663255 (case), Lot number 25HBN050; Medline product number/SKU DYNJ0408782AC, UDI/DI 10198459335945 (each) 40198459335946 (case), Lot number 25HBM986; Medline product number/SKU DYNJ67308B, UDI/DI 10198459424328 (each) 40198459424329 (case), Lot number 25HBM143; Medline product number/SKU DYNJ911274A, UDI/DI 10198459424236 (each) 40198459424237 (case), Lot number 25HBK642; Medline product number/SKU DYNJ43777L, UDI/DI 10198459318290 (each) 40198459318291 (case), Lot number 25HBK035; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25HBH203; Medline product number/SKU DYNJ87021B, UDI/DI 10198459239618 (each) 40198459239619 (case), Lot number 25HBA632; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 25HBA572; Medline product number/SKU DYNJ63135D, UDI/DI 10198459372636 (each) 40198459372637 (case), Lot number 25GMG817; Medline product number/SKU DYNJ0660029AL, UDI/DI 10195327638474 (each) 40195327638475 (case), Lot number 25GMF304; Medline product number/SKU DYNJ04470J, UDI/DI 10888277745391 (each) 40888277745392 (case), Lot number 25GMC619; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 25GMC545; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 25GMB055; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 25GDB608; Medline product number/SKU DYNJ54094F, UDI/DI 10198459286247 (each) 40198459286248 (case), Lot number 25GBY110; Medline product number/SKU DYNJ67142G, UDI/DI 10198459295065 (each) 40198459295066 (case), Lot number 25GBX084; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25GBW251; Medline product number/SKU DYNJ87331B, UDI/DI 10198459205309 (each) 40198459205300 (case), Lot number 25GBV747; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25GBU558; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25GBQ314; Medline product number/SKU DYNJ53741M, UDI/DI 10198459024955 (each) 40198459024956 (case), Lot number 25GBP994; Medline product number/SKU DYNJ40396C, UDI/DI 10198459047275 (each) 40198459047276 (case), Lot number 25GBP442; Medline product number/SKU DYNJ42920C, UDI/DI 10195327649005 (each) 40195327649006 (case), Lot number 25GBL350; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 25GBH984; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 25GBH440; Medline product number/SKU DYNJ54094F, UDI/DI 10198459286247 (each) 40198459286248 (case), Lot number 25GBH384; Medline product number/SKU DYNJ41230K, UDI/DI 10193489675634 (each) 40193489675635 (case), Lot number 25GBH087; Medline product number/SKU DYNJ0541930P, UDI/DI 10198459293894 (each) 40198459293895 (case), Lot number 25GBE986; Medline product number/SKU DYNJ53741M, UDI/DI 10198459024955 (each) 40198459024956 (case), Lot number 25GBE845; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 25GBD657; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 25FMJ253; Medline product number/SKU DYNJ63135D, UDI/DI 10198459372636 (each) 40198459372637 (case), Lot number 25FMH933; Medline product number/SKU DYNJ85751, UDI/DI 10195327542917 (each) 40195327542918 (case), Lot number 25FMH295; Medline product number/SKU DYNJ04470J, UDI/DI 10888277745391 (each) 40888277745392 (case), Lot number 25FMF411; Medline product number/SKU DYNJ0660029AL, UDI/DI 10195327638474 (each) 40195327638475 (case), Lot number 25FMF190; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 25FMD030; Medline product number/SKU DYNJ48310I, UDI/DI 10198459259852 (each) 40198459259853 (case), Lot number 25FBW018; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25FBT554; Medline product number/SKU DYNJ65416D, UDI/DI 10198459117404 (each) 40198459117405 (case), Lot number 25FBR416; Medline product number/SKU DYNJ31902O, UDI/DI 10195327691226 (each) 40195327691227 (case), Lot number 25FBR084; Medline product number/SKU DYNJ04822X, UDI/DI 10198459360015 (each) 40198459360016 (case), Lot number 25FBQ612; Medline product number/SKU DYNJ0271227Q, UDI/DI 10195327589455 (each) 40195327589456 (case), Lot number 25FBQ516; Medline product number/SKU DYNJ52036G, UDI/DI 10195327663254 (each) 40195327663255 (case), Lot number 25FBO160; Medline product number/SKU DYNJ53741M, UDI/DI 10198459024955 (each) 40198459024956 (case), Lot number 25FBO121; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 25FBM682; Medline product number/SKU DYNJ53741M, UDI/DI 10198459024955 (each) 40198459024956 (case), Lot number 25FBM347; Medline product number/SKU DYNJ80520B, UDI/DI 10198459154362 (each) 40198459154363 (case), Lot number 25FBK802; Medline product number/SKU DYNJ87331B, UDI/DI 10198459205309 (each) 40198459205300 (case), Lot number 25FBJ468; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 25FBI224; Medline product number/SKU DYNJ42920C, UDI/DI 10195327649005 (each) 40195327649006 (case), Lot number 25FBG125; Medline product number/SKU DYNJ40396C, UDI/DI 10198459047275 (each) 40198459047276 (case), Lot number 25FBF324; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25FBF299; Medline product number/SKU DYNJ53927M, UDI/DI 10198459259821 (each) 40198459259822 (case), Lot number 25FBF246; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25FBF028; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25FBD922; Medline product number/SKU DYNJ67142G, UDI/DI 10198459295065 (each) 40198459295066 (case), Lot number 25FBC700; Medline product number/SKU DYNJ63135C, UDI/DI 10198459292392 (each) 40198459292393 (case), Lot number 25EMF810; Medline product number/SKU DYNJ04478S, UDI/DI 10198459225987 (each) 40198459225988 (case), Lot number 25EME086; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 25EMC181; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 25EMA779; Medline product number/SKU DYNJ80520B, UDI/DI 10198459154362 (each) 40198459154363 (case), Lot number 25EBT296; Medline product number/SKU DYNJ31902O, UDI/DI 10195327691226 (each) 40195327691227 (case), Lot number 25EBR153; Medline product number/SKU DYNJ62691D, UDI/DI 10198459189838 (each) 40198459189839 (case), Lot number 25EBR048; Medline product number/SKU DYNJ87331B, UDI/DI 10198459205309 (each) 40198459205300 (case), Lot number 25EBO032; Medline product number/SKU DYNJ52036G, UDI/DI 10195327663254 (each) 40195327663255 (case), Lot number 25EBN416; Medline product number/SKU DYNJ81096B, UDI/DI 10195327590673 (each) 40195327590674 (case), Lot number 25EBN378; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 25EBM943; Medline product number/SKU DYNJ41230K, UDI/DI 10193489675634 (each) 40193489675635 (case), Lot number 25EBL315; Medline product number/SKU DYNJ0271227Q, UDI/DI 10195327589455 (each) 40195327589456 (case), Lot number 25EBK900; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25EBK558; Medline product number/SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot number 25EBH969; Medline product number/SKU DYNJ0408782AC, UDI/DI 10198459335945 (each) 40198459335946 (case), Lot number 25EBH563; Medline product number/SKU DYNJ53741M, UDI/DI 10198459024955 (each) 40198459024956 (case), Lot number 25EBH203; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 25EBC844; Medline product number/SKU DYNJ65416D, UDI/DI 10198459117404 (each) 40198459117405 (case), Lot number 25EBC487; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25EBC108; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25EBA573; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25EBA338; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 25DMD637; Medline product number/SKU DYNJ0660029AL, UDI/DI 10195327638474 (each) 40195327638475 (case), Lot number 25DMD384; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 25DMB631; Medline product number/SKU DYNJ0369758P, UDI/DI 10198459230356 (each) 40198459230357 (case), Lot number 25DLB109; Medline product number/SKU DYNJ0369758P, UDI/DI 10198459230356 (each) 40198459230357 (case), Lot number 25DLA388; Medline product number/SKU DYNJ31902O, UDI/DI 10195327691226 (each) 40195327691227 (case), Lot number 25DBU423; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 25DBU062; Medline product number/SKU DYNJ04822W, UDI/DI 10198459338144 (each) 40198459338145 (case), Lot number 25DBS734; Medline product number/SKU DYNJ54094F, UDI/DI 10198459286247 (each) 40198459286248 (case), Lot number 25DBR858; Medline product number/SKU DYNJ906113A, UDI/DI 10198459266836 (each) 40198459266837 (case), Lot number 25DBQ991; Medline product number/SKU DYNJ17449N, UDI/DI 10195327692940 (each) 40195327692941 (case), Lot number 25DBO128; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25DBN173; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25DBL585; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25DBK014; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 25DBJ241; Medline product number/SKU DYNJ31902O, UDI/DI 10195327691226 (each) 40195327691227 (case), Lot number 25DBI699; Medline product number/SKU DYNJ53927M, UDI/DI 10198459259821 (each) 40198459259822 (case), Lot number 25DBI676; Medline product number/SKU DYNJ40396C, UDI/DI 10198459047275 (each) 40198459047276 (case), Lot number 25DBG901; Medline product number/SKU DYNJ906113A, UDI/DI 10198459266836 (each) 40198459266837 (case), Lot number 25DBF597; Medline product number/SKU DYNJ80520B, UDI/DI 10198459154362 (each) 40198459154363 (case), Lot number 25DBD876; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 25DBD137; Medline product number/SKU DYNJ0541930P, UDI/DI 10198459293894 (each) 40198459293895 (case), Lot number 25DBC067; Medline product number/SKU DYNJ906113A, UDI/DI 10198459266836 (each) 40198459266837 (case), Lot number 25DBB264; Medline product number/SKU DYNJ42489I, UDI/DI 10198459180699 (each) 40198459180690 (case), Lot number 25CMD761; Medline product number/SKU DYNJ0660029AL, UDI/DI 10195327638474 (each) 40195327638475 (case), Lot number 25CMC713; Medline product number/SKU DYNJ53121, UDI/DI 10884389434093 (each) 40884389434094 (case), Lot number 25CMC309; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 25CDB954; Medline product number/SKU DYNJ52036G, UDI/DI 10195327663254 (each) 40195327663255 (case), Lot number 25CBU215; Medline product number/SKU DYNJ31285J, UDI/DI 10198459107023 (each) 40198459107024 (case), Lot number 25CBT188; Medline product number/SKU DYNJ80520B, UDI/DI 10198459154362 (each) 40198459154363 (case), Lot number 25CBR386; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25CBP215; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 25CBP213; Medline product number/SKU DYNJ62691D, UDI/DI 10198459189838 (each) 40198459189839 (case), Lot number 25CBO326; Medline product number/SKU DYNJ65416D, UDI/DI 10198459117404 (each) 40198459117405 (case), Lot number 25CBK948; Medline product number/SKU DYNJ48310I, UDI/DI 10198459259852 (each) 40198459259853 (case), Lot number 25CBK947; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 25CBJ974; Medline product number/SKU DYNJ87331B, UDI/DI 10198459205309 (each) 40198459205300 (case), Lot number 25CBJ846; Medline product number/SKU DYNJ31902O, UDI/DI 10195327691226 (each) 40195327691227 (case), Lot number 25CBJ058; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 25CBD391; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 25CBC202; Medline product number/SKU DYNJ53927M, UDI/DI 10198459259821 (each) 40198459259822 (case), Lot number 25CBA139; Medline product number/SKU DYNJ0199156V, UDI/DI 10198459032882 (each) 40198459032883 (case), Lot number 25BMI543; Medline product number/SKU DYNJ0660029AL, UDI/DI 10195327638474 (each) 40195327638475 (case), Lot number 25BMH978; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 25BMH318; Medline product number/SKU DYNJ85751, UDI/DI 10195327542917 (each) 40195327542918 (case), Lot number 25BMF529; Medline product number/SKU DYNJ53121, UDI/DI 10884389434093 (each) 40884389434094 (case), Lot number 25BMA883; Medline product number/SKU DYNJ0369758P, UDI/DI 10198459230356 (each) 40198459230357 (case), Lot number 25BLB051; Medline product number/SKU DYNJ0369758P, UDI/DI 10198459230356 (each) 40198459230357 (case), Lot number 25BLA122; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25BBT404; Medline product number/SKU DYNJ67142F, UDI/DI 10195327668167 (each) 40195327668168 (case), Lot number 25BBR015; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 25BBN386; Medline product number/SKU DYNJ31205K, UDI/DI 10198459211003 (each) 40198459211004 (case), Lot number 25BBN141; Medline product number/SKU DYNJ80520B, UDI/DI 10198459154362 (each) 40198459154363 (case), Lot number 25BBE710; Medline product number/SKU DYNJ53927M, UDI/DI 10198459259821 (each) 40198459259822 (case), Lot number 25BBD766; Medline product number/SKU DYNJ53741M, UDI/DI 10198459024955 (each) 40198459024956 (case), Lot number 25BBC322; Medline product number/SKU DYNJ87331B, UDI/DI 10198459205309 (each) 40198459205300 (case), Lot number 25BBB730; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 25BBA216; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 25AMG339; Medline product number/SKU DYNJ67363A, UDI/DI 10195327687014 (each) 40195327687015 (case), Lot number 25AME911; Medline product number/SKU DYNJ33414J, UDI/DI 10195327538873 (each) 40195327538874 (case), Lot number 25AMA739; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 25AMA147; Medline product number/SKU DYNJ0369758P, UDI/DI 10198459230356 (each) 40198459230357 (

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0176-2027
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.