FDA-Device2026-09-30Class IIPROCESSING DEFECT

Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges

OTHERNationwide distributionMedical devices

What this means

Medline's Convenience Kits Major Pack (catalog number DYNJ81325A) contain neurological sponges with unexpectedly high levels of endotoxin, a bacterial byproduct. These elevated levels could trigger serious medical reactions including fever, inflammation, or low blood pressure that may require medical care.

  • Check if you have Medline Convenience Kits Major Pack (DYNJ81325A) with lot number 23HBB258.
  • Contact Medline or your healthcare facility immediately if you have or used these kits.
  • Do not use affected kits; follow your facility's guidance on safe disposal or return.
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
128 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3266-2026

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