Home / Recalls / Medline Industries, LP / Z-0175-2027

Z-0175-2027 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-0175-2027 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: 235 kits.

Recall Details

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

Product Description

Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.

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 DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 26BBA206; Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 25LBQ023; Medline Product Number/SKU DYNJ0538615L; UDI/DI 10198459414152 (each) 40198459414153 (case), Lot number 25KBR149; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 25EBF588; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 25ABI296; Medline Product Number/SKU DYNJ0538615K; UDI/DI 10198459136429 (each) 40198459136420 (case), Lot number 24IBP190; Medline Product Number/SKU DYNJ0538615J; UDI/DI 10195327673376 (each) 40195327673377 (case), Lot number 24DBC864.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0175-2027
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.

Other recalls by Medline Industries, LP

  • Z-0189-2027 Class II — Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A (Sep 11, 2026)
  • Z-0170-2027 Class II — Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline… (Sep 2, 2026)
  • Z-0172-2027 Class II — Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline… (Sep 2, 2026)
  • Z-0179-2027 Class II — Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product… (Sep 2, 2026)
  • Z-0174-2027 Class II — Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA… (Sep 2, 2026)
  • Z-0178-2027 Class II — Medline surgical convenience kits labeled as: OPEN HEART, Medline Product… (Sep 2, 2026)
  • Z-0177-2027 Class II — Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK… (Sep 2, 2026)
  • Z-0173-2027 Class II — Medline surgical convenience kits labeled as: 1) EAR, Medline product… (Sep 2, 2026)
  • Z-0176-2027 Class II — Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B… (Sep 2, 2026)
  • Z-0171-2027 Class II — Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF… (Sep 2, 2026)

FDA data resources