FDA Medical devices recall ·
Medline Sterile Laparoscopy Pack, DYNJ68187A ( recall
- Recall number
- Z-0053-2025
- Date
- (initiated August 28, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 72 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution in the state of CA.
States: California
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0053-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.