Official recall record
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001;
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-08-10
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10198459778865
- Brand on record
- Medline Industries, LP
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-22.
Record last checked against the registry on 2026-10-22.
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