FDA-Device2026-09-09Class IIPROCESSING DEFECT
Halyard medical surgical kits recalled for neurological sponges with variable endotoxin levels
What this means
Halyard medical convenience kits contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that can trigger immune reactions in patients. The affected kits were distributed nationwide to surgical facilities.
- Check your facility inventory for the affected kit model numbers and lot numbers listed in the recall notice.
- Do not use affected kits; quarantine them and contact your Halyard or Medicom representative.
- Return the kits according to instructions from your supplier or the manufacturer.
The agency's original wording
Hazard
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
Affected count
816 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3046-2026More AVID Medical recalls
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
- FDA-Device2026-09-09Halyard medical convenience kits recalled for neurological sponges with inconsistent endotoxin levels
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
- FDA-Device2026-07-29Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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