Montreal, N/A, Canada
AMD Medicom Inc. recalls
3 recalls recorded since 2018, most recently on 8 May 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 May 2026
- 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.
- Distribution
- US: MT, NC, VA, CA, TX, OH, TN, IL, RI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2458-2026, Z-2459-2026
- 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
- Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Ongoing Class II Medical devices
- Recall started
- 21 December 2023
- Reason
- Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- Distribution
- US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1148-2024, Z-1146-2024, Z-1147-2024
- PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
- HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
- HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Terminated Class II Medical devices
- Recall started
- 11 October 2019
- Terminated
- 14 September 2021
- Reason
- 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.
- Distribution
- The products were distributed tot he following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were distributed to the following foreign countries: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0494-2020, Z-0495-2020
- MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
- MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.