AMD Medicom Inc. recalls Ritmed Neurological Sponges

Recalling company

AMD Medicom Inc.

Product

Ritmed 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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 8, 2026

Reported

Jun 24, 2026

Distribution

US: MT, NC, VA, CA, TX, OH, TN, IL, RI

Status

Ongoing

Quantity

7,838,200

Lot / codes

UDI-DI: 20686864043205. Distributed After May 1st, 2022, including the following lots: 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

Company location

Montreal

Recall type

Voluntary: Firm initiated

Recall number

Z-2458-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2458-2026 in the FDA Enforcement Report. Also see FDA recall press releases.