Summary
The FDA issued a Class II for Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C by AMD Medicom Inc.. Reason: Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision,.
Details
Source
Device Recall
External ID
Z-2459-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Lot/Code Info: UDI-DI: 10686864044465, Lot: 17936
Quantity Affected: 10
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.
Distribution
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-08
Company
Montreal
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AMD Medicom Inc. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AMD Medicom Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AMD Medicom Inc. have FDA actions?
AMD Medicom Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2459-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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