FDA recall, , Moderate risk
AMD Medicom Ritmed Neurological Sponges
Ritmed Neurological Sponges may not consistently meet endotoxin specification for devices that contact cerebrospinal fluid.
Summary by Recall Canary from the FDA notice
What happened
AMD Medicom Inc. of Montreal, Canada, began a recall on May 8, 2026, for Ritmed Neurological Sponges, which are used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision.
The sponges may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid, and elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea. The recall was added to the FDA's Enforcement Report on June 16, 2026, and was classified by the FDA on the same date.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI, lot code and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Ritmed Neurological Sponges, Description/REF
- UDI-DI
- 20686864043205
- Lot code
- 19316
- 16409
- 15463-7
- 15463-6
- 15463-5
- 15463-4
- 15463-3
- 15463-2
- 15463-1
- 15463
- 15192-1
- 15192
- 14813
- 14039
- 13673
- 13289
- 12641
- 12206
- 11851
- 11020-1
- 11020
- 10586
- 10392
- 9243
- 8160
- 7784
- 7748
- 7044
Ritmed Neurological Sponges, 0.75x0.75in, Sterile
- UDI-DI
- 10686864044465
- Reference number
- 85995C
- Lot code
- 17936
Recall details
- Company began the recall
- Company
- AMD Medicom Inc.Montreal, Canada
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99006
- Recall numbers
- Z-2458-2026 to Z-2459-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
