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Medline Industries, Inc. DYNJVB91001Recalls & reported problems

Medline Industries, Inc. · CRANIOTOMY #IMF 56646-LF · Class 1

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
4

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

4 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 10, 2026Open, Classified

    The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

    Z-3269-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

  2. Mar 19, 2026Open, Classified

    During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

    Z-2038-2026 · Root cause: Under Investigation by firm · FDA record ↗

  3. Nov 21, 2024Open, Classified

    Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

    Z-0794-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

  4. Nov 6, 2024Open, Classified

    Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

    Z-0726-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.