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Medline Industries, Inc. DYNJ905330BRecalls & reported problems

Medline Industries, Inc. · CRANIOTOMY · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

5 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
5

Summary

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

5 FDA recall records name this device's identifier, 5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Mar 19, 2026Class IIOpen, 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 · Recall details · FDA record ↗

  2. Nov 21, 2024Class IIOpen, 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 · Recall details · FDA record ↗

  3. May 18, 2023Class IIOpen, Classified

    Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

    Z-2205-2023 · Root cause: Device Design · Recall details · FDA record ↗

  4. May 18, 2023Class IIOpen, Classified

    Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

    Z-2137-2023 · Root cause: Process control · Recall details · FDA record ↗

  5. Nov 17, 2022Class IIOpen, Classified

    Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

    Z-1096-2023 · Root cause: Device Design · Recall details · FDA record ↗

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Sources and updates

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