FDAMay 8, 2026device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
amd medicomamd
UPCs
20686864043205
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARitmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C2026-05-08
- FDAPATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)2023-12-21
- FDAHENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)2023-12-21
- FDAHENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)2023-12-21
- FDAMEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 20422019-10-11
- FDAMEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 20402019-10-11
- FDAAMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 141502016-06-08
- FDAAMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- T...2016-03-30
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