AMD Medicom Recalls
7 recalls on record · November 27, 2019 to June 24, 2026 · Medical Devices
Recalls by year
19
24
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2026Medical DevicesFDA
AMD Medicom Inc. recalls Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
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.
June 24, 2026Medical DevicesFDA
AMD Medicom Inc. recalls Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.
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.
February 28, 2024Medical DevicesFDA
AMD Medicom Inc. recalls PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Hazard: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
February 28, 2024Medical DevicesFDA
AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Hazard: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
February 28, 2024Medical DevicesFDA
AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Hazard: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
November 27, 2019Medical DevicesFDA
AMD Medicom Inc. recalls MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
Hazard: Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.
November 27, 2019Medical DevicesFDA
AMD Medicom Inc. recalls MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
Hazard: Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.