Home / Recalls / Medline Industries, LP / Z-0177-2027

Z-0177-2027 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-0177-2027 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: 1900 kits.

Recall Details

Product Type
Devices
Report Date
Oct 21, 2026
Initiation Date
Sep 2, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1900 kits

Product Description

Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.

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 DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26BBC545; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26ABM193; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25LBD334; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25JBL305; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25IBF209; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25HBI041; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25FBF808; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25EBO692; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25DBG912; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25BBS302; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25ABN459; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24LBQ417; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBL387; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBB074; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24IBI827; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24HBL301; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22CLA280; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22ALA687; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21KLA284; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21JLA298; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21HLA613; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21GLA706; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21DLA076; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21ALA482; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 20LLA600.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0177-2027
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-0173-2027 Class II — Medline surgical convenience kits labeled as: 1) EAR, Medline product… (Sep 2, 2026)
  • Z-0175-2027 Class II — Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline… (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