Severity
Moderate
FDA Devices recall · Reported October 16, 2024
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 th…
Medline Industries, LP - Northfield recalled Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unima… - a moderate-severity action.
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unima… was recalled by Medline Industries, LP - Northfield in October 16, 2024. Reason: CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. …. Check the official notice for the remedy. Verify recall #Z-0053-2025 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0053-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0053-2025) was formally reported on October 16, 2024, with the manufacturer initiating the action on August 28, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 72 kits.
The documented reason for this recall is: 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, … Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
72 kits
Related Recalls
6
3 from same agency
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0053-2025 |
| Date reported | October 16, 2024 |
| Date initiated | August 28, 2024 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 72 kits |
| Distribution | US Nationwide distribution in the state of CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 16, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.