Z-0053-2025 Class II Ongoing
FDA device recall Z-0053-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Aug 28, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 72 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 16, 2024
- Initiation Date
- Aug 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 kits
Product Description
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 Pattern
US Nationwide distribution in the state of CA.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0053-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026