Reported Jun 24, 2026 · Ongoing
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in,…
AMD Medicom Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AMD Medicom Inc. · 2555 Ch de L'Aviation · Montreal · N/A
Is this the product you have?
- Ritmed Neurological Sponges
- Description/REF
0.5x0.5inNon-Sterile/55992C0.5x1.0inNon-Sterile/55993C0.5x3.0inNon-Sterile/55994C0.75x0.75inNon-Sterile/55995C1.0x1.0inNon-Sterile/55996C1.0x3.0inNon-Sterile/55997C0.5x1.5inNon-Sterile/55998C
- Lot codes and dates
- UDI-DI
20686864043205. Distributed After May 1st2022
- including the following lots
193161640915463-715463-615463-515463-415463-315463-215463-11546315192-1151921481314039136731328912641122061185111020-111020105861039292438160778477487044
- UDI-DI
- Amount recalled
- 7,838,200
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new AMD Medicom Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.