Home / Recalls / Medline Industries, LP / Z-0169-2027

Z-0169-2027 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-0169-2027 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: 1834 kits.

Recall Details

Product Type: Devices
Report Date: Oct 21, 2026
Initiation Date: Sep 2, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1834 kits

Product Description

1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P; 5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J; 6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K; 7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937; 8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D; 9) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879; 10) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879C; 11) Product Name CARDIAC SURGERY, Medline Kit Number/SKU DYNJ911589A; 12) Product Name AV SHUNT-MARYVIEW, Medline Kit Number/SKU DYNJ911710; 13) Product Name CARDIAC ACCESSORY PACK, Medline Kit Number/SKU DYNJT7607.

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 DYNJ911589A, UDI/DI 10198459646102 (each) 40198459646103 (case), Lot Number 26CBD487; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 26BLA622; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 26ADA368; Medline product number/SKU DYNJT7607, UDI/DI 10198459639470 (each) 40198459639471 (case), Lot Number 26ABP608; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25KLA755; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25KDA055; Medline product number/SKU DYNJ911710, UDI/DI 10198459515705 (each) 40198459515706 (case), Lot Number 25JLA081; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25JBQ932; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25IDA242; Medline product number/SKU DYNJ80549D, UDI/DI 10198459389610 (each) 40198459389611 (case), Lot Number 25HBV035; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ELA868; Medline product number/SKU DYNJ35312K, UDI/DI 10198459311574 (each) 40198459311575 (case), Lot Number 25EDA603; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA807; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25BLA545; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 25ALA107; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA717; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24LDA627; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24KLA675; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24KBD462; Medline product number/SKU DYNJ24528P, UDI/DI 10198459129537 (each) 40198459129538 (case), Lot Number 24JLA497; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24IBQ955; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24HLA074; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24HDA135; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24GLA306; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24GBA028; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24FLA524; Medline product number/SKU DYNJ908879C, UDI/DI 10195327690885 (each) 40195327690886 (case), Lot Number 24FBI615; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 24EDA934; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 24BLA262; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23LLA290; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23LDA007; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB898; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23KDB325; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ILA783; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23IDB477; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA825; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23HLA102; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23EMA351; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23EDC422; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23DLA106; Medline product number/SKU DYNJ22052I, UDI/DI 10195327355012 (each) 40195327355013 (case), Lot Number 23CME779; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23CLA041; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23CDB348; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDB876; Medline product number/SKU DYNJ35312J, UDI/DI 10195327209810 (each) 40195327209811 (case), Lot Number 23BDA883; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 23ALA790; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22KLB130; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22JLA337; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22ILA503; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22HLB081; Medline product number/SKU DYNJ908879, UDI/DI 10195327203429 (each) 40195327203420 (case), Lot Number 22HBX489; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22HBR302; Medline product number/SKU DYNJ24528O, UDI/DI 10195327164836 (each) 40195327164837 (case), Lot Number 22GLA012; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22FBR986; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22DLA370; Medline product number/SKU DYNJ24528N, UDI/DI 10195327125257 (each) 40195327125258 (case), Lot Number 22CLA935; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 22CBY756; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21VBC303; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBE903; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21LBD590; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBO692; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21BBK081; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABW871; Medline product number/SKU DYNJ43937, UDI/DI 10888277077966 (each) 40888277077967 (case), Lot Number 21ABB682.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0169-2027
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

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

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