Z-0053-2025Class II

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

Name: Z-0053-2025 Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-08-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-08-28 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket on 2024-08-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0053-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-28
Posted: 2024-10-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Product code: FDE Laparoscopy Kit
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.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: 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.
Quantity in commerce: 72 kits
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0053-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0053-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-10

Product code FDE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)