Medline Sterile Laparoscopy Pack — Class II medical device recall Z-0053-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-16, distributed nationwide. CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. Th
| Recall number | Z-0053-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-08-28 |
| Classified | 2024-10-10 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 72 kits |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10195327384494 |
| Lot numbers | 23LMA745, 24AMA209, 24BMB025 |
| Expiration dates | 2025-06-30, 2025-07-31, 2025-08-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0053-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.