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FDAFDA recall Z-0174-2027 · Oct 21, 2026

Medline Industries, LP: Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK recall

Recall found

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 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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification
Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status
Ongoing
Codes, lots and dates
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.
Quantity
472 kits
Distribution
US Nationwide distribution.
Recalling firm
Medline Industries, LP, Northfield, IL
Voluntary or mandated
Voluntary: Firm initiated
Recall started
2026-09-02

Source: openFDA enforcement record Z-0174-2027 · search recall number Z-0174-2027 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.

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