FDA Device recall Z-0053-2025
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket by Medline Industries Northfield, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0053-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-28 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Reason
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.
Identifiers
| code_info | Lot numbers 24AMA209, exp. 2025-06-30; 24BMB025, exp. 2025-08-31; 23LMA745, exp. 2025-07-31; UDI-DI each 10195327384494, UDI-DI case-40195327384495 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0053-2025%22
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