Medline Industries, Inc. CDS985246KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327324704), received between Feb 22, 2023 and Feb 22, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 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-2033-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2023Break; Break

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 DURING A "MULTI-LEVEL LUMBAR LAMI CASE" WHEN USING A NEURO CUSTOM PACK THE INSULATION BOVIE TIP FELL OFF AND "WAS RECOVERED IN THE SURGICAL WOUND INTACT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419885 ↗
• InjuryFeb 22, 2023Break; Break

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 DURING A "MULTI-LEVEL LUMBAR LAMI CASE" WHEN USING A NEURO CUSTOM PACK THE INSULATION BOVIE TIP FELL OFF AND "WAS RECOVERED IN THE SURGICAL WOUND INTACT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417869 ↗