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U.S. Department of Health and Human Services

Class 2 Device Recall Ritmed Nurological Sponges

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 Class 2 Device Recall Ritmed Nurological Spongessee related information
Date Initiated by FirmMay 08, 2026
Date PostedJune 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2458-2026
Recall Event ID 99006
510(K)NumberK830269 
Product Classification Gauze/sponge, internal - Product Code EFQ
ProductRitmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
Code Information UDI-DI: 20686864043205. Distributed After May 1st, 2022
FEI Number 3002677549
Recalling Firm/
Manufacturer		 AMD Medicom Inc.
2555 Ch de L'Aviation
Montreal Canada
Manufacturer Reason
for Recall		Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 5/8/2026, recall notices were emailed to customers who were asked to do the following: 1) Discontinue use, quarantine and destroy affected devices. 2) Notify any customers or facilities to whom you have distributed this product. 3) Complete and return the response form via email to firm's customer service at Claims@medicom.ca
Quantity in Commerce7,838,200
DistributionUS: MT, NC, VA, CA, TX, OH, TN, IL, RI
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EFQ
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