Lower risk Medical device recall · FDA · Published August 28, 2024

Medline Sterile Laparoscopy Pack Recall: Endo Pocket May Stretch Out

Medline recalls sterile laparoscopy packs with ConMed Unimax Detachable Endo Pocket that may stretch out during use. Affected lots expire by 2025. Contact Medline for replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0053-2025Medical device Medline ›

Lower-risk recall

CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.

Take action

Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753

✎ GovInfoNow plain-language explainer

Medline is recalling sterile laparoscopy packs that contain a ConMed Unimax Detachable Endo Pocket. This component may stretch out from the pouch opening if not properly fixed during manufacturing, potentially causing issues during medical procedures. Read more at govinfonow.com/recall/54157-medline-sterile-laparoscopy-pack-recall-endo-pocket-may-stretch-out.

Source Summary by GovInfoNow · govinfonow.com/recall/54157-medline-sterile-laparoscopy-pack-recall-endo-pocket-may-stretch-out · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0053-2025

Cite this page

“Medline Sterile Laparoscopy Pack Recall: Endo Pocket May Stretch Out.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54157-medline-sterile-laparoscopy-pack-recall-endo-pocket-may-stretch-out. Based on FDA recall #Z-0053-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0053-2025%22&limit=1).

The FDA announced on 2024-08-28 that Medline Industries, LP is recalling the Medline Sterile Laparoscopy Pack, DYNJ68187A, due to a potential component failure. The hazard involves the ConMed/Unimax Detachable Endo Pocket tube stretching out during removal.

How to tell if you have it

Brand: Medline
Product: Medline Sterile Laparoscopy Pack, DYNJ68187A (REF)
Component: ConMed/Unimax Detachable Endo Pocket
Lot numbers: 24AMA209, 24BMB025, 23LMA745
Expiration dates: 2025-06-30, 2025-08-31, 2025-07-31
UDI-DI: 10195327384494, UDI-DI case-40195327384495
Quantity: 72 kits
Distribution: US Nationwide distribution in the state of CA

The hazard

The tube inside the pouch may stretch out from the pouch opening if it is not precisely fixed during production. This defect affects the product's function as a receptacle for collecting and extracting tissues, organs, and calculi.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since 2021-10-22. Recent Medline recalls include light failure in newborn resuscitation kits (2025-07-25), incorrect labeling in Foley Tray Kits (2025-07-23), and particulates in reprocessed catheters (2025-07-14). Other recent recalls of similar products include Medline Surgical Packs Recall: Calibration Issues May Impact Sterility (2026-01-07) and Medline Pelvic Lap Pack Kits: Catheter Issues Recalled (2026-05-04).

How to tell if you have this one

Check for Medline Sterile Laparoscopy Packs with lot numbers 24AMA209 (expires 2025-06-30), 24BMB025 (expires 2025-08-31), or 23LMA745 (expires 2025-07-31). The product has a unique identifier (UDI-DI) of 10195327384494 or 40195327384495.

Brand
Medline
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 24AMA209, 24BMB025, or 23LMA745 on the pack.
Contact Medline for Replacement
Medline will provide a replacement kit if you have the affected product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 49 days after the firm started it.

Aug 28, 2024Firm started the recall
Oct 10, 2024FDA classified it Class II
Oct 16, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/54157-medline-sterile-laparoscopy-pack-recall-endo-pocket-may-stretch-out">Medline Sterile Laparoscopy Pack Recall: Endo Pocket May Stretch Out (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0053-2025 (August 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0053-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.