CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

Medline surgical convenience kits labeled as recalled

Medline Industries is recalling Medline surgical convenience kits labeled as: Main/Laparoscopy Transpla Pack, Medline, distributed nationwide in the US. The recall was initiated on 2 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline 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 recalled472 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0174-2027
FDA event ID: 99886
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 2 Sep 2026
FDA classified: 15 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

2 Sep 2026	Recall initiated by company
15 Oct 2026	Classified by FDA	+43 days
21 Oct 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 99886

This product is part of a recall event; the main page for the event is Medline surgical convenience kits labeled as: Open Heart recalled.

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as: Open Heart recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Product Name Aud Open Heart Pack, Medline Kit Number recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide

More recalls from Medline Industries

All 726

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,902

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Scout MD recalled by Merit Medical Systems	Merit Medical Systems	Other	7 states
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide