Home / Recalls / Medline Industries, LP / Z-0174-2027

Z-0174-2027 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-0174-2027 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: 472 kits.

Recall Details

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

Product Description

Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I; 4) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AA.

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 DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 25GME600; Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 25DMJ601; Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 25CMA596; Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 24FMB407; Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 24CMH524; Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 23LMF661; Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 23JME256; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23GMB142; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23FMH674; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23BMC121; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23AMB446; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22KMG366; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22GMB609; Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 22DDA108; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22CME324; Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 22CDB128; Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 22BDA125; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22AMG393; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21LMF161; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21LMB777; Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 21JDC440; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21GME576; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21FMC491; Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21CME380; Medline product number/SKU DYNJ0656274AA, UDI/DI 10193489827095 (each) 40193489827096 (case), lot number 21BMD994; Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 21ADA403.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0174-2027
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-0175-2027 Class II — Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline… (Sep 2, 2026)
  • Z-0179-2027 Class II — Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product… (Sep 2, 2026)
  • Z-0172-2027 Class II — Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline… (Sep 2, 2026)
  • Z-0173-2027 Class II — Medline surgical convenience kits labeled as: 1) EAR, Medline product… (Sep 2, 2026)
  • Z-0178-2027 Class II — Medline surgical convenience kits labeled as: OPEN HEART, Medline Product… (Sep 2, 2026)
  • Z-0170-2027 Class II — Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, 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-0177-2027 Class II — Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK… (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