RecallRadar

FDA Device recall Z-0174-2027

Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC

On 2026-10-21 the FDA classified a Class II recall of Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC by Medline Industries, citing 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 duri….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0174-2027
ClassificationClass II
Statusongoing
Initiated2026-09-02
Published2026-10-21
Last updated2026-10-27 05:30 UTC
CompanyMedline Industries
DistributionUS

Product

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

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.

Identifiers

code_info
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 25GME600; Med…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) 4

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.

Other recalls by Medline Industries

All Medline Industries recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0174-2027%22

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