Medline Sterile Laparoscopy Pack, DYNJ68187A (REF)… recallZ-0053-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Aug 28, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

The recalling firm issued letters on and dated 8/28/2024 via first class mail and email. The letter explained the reason for recall and instructed the customer that nothing was to be returned to Medline. The customer is to request a sticker to be placed on affected kits instructing the user to remove the recalled component. The consignee is required to immediately check their stock for the affected item number and affected lot numbers which can be located within the recall portal and quarantine all affected product immediately. The consignee is to use the link and information in the letter to complete their response form. They are to list the quantity of affected product in inventory on the form and submit the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the user to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify their downstream customers of this communication.

Recall details

Recall number: Z-0053-2025
Status: Open, Classified
Initiated by the company: Aug 28, 2024
Posted by the FDA: Oct 10, 2024
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 72 kits
Product code: FDE
Distribution: US Nationwide distribution in the state of CA.

Product description

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

Code information (models, lots, serial 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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Medline Industries, Inc. DYNJ68187A
Medline Industries, Inc. · laparoscopy kit
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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