# FDA recall Z-0053-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-08-28.

## Product

Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

## Reason for 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.

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-0053-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-28
- **Report date:** 2024-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2025

## Citation

> AI Analytics. FDA recall Z-0053-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0053-2025. Source: US FDA. Licensed CC0.

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