Class II

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

MEDLINE INDUSTRIES, LP - Northfield · August 28, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

72 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0053-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

MEDLINE INDUSTRIES, LP - Northfield Medical Device Recall: Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket | SafeCheck