Lower riskMedical device recall · FDA · Published December 21, 2023
PATTERSON PROCEDURE Anti-Fog Earloop Masks Recall: Level 3 Masks Made on Unvalidated
AMD Medicom Inc. recalls anti-fog earloop masks (item code 127-757: blue, ASTM Level 3) made on unvalidated equipment. These masks may not meet safety standards.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
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Contact the company
📍Recalling firmAMD Medicom Inc.2555 Ch de L'Aviation · Montreal, Canada
“PATTERSON PROCEDURE Anti-Fog Earloop Masks Recall: Level 3 Masks Made on Unvalidated.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56490-patterson-procedure-anti-fog-earloop-masks-recall-level-3-masks. Based on FDA recall #Z-1148-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2024%22&limit=1).
AMD Medicom Inc. recalled PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) on Dec. 21, 2023, according to the FDA. The masks were produced on alternate non-validated production equipment not included in initial product qualification.
Quantity: 180 cases (10 boxes/case and 50 masks/box)
Distribution: US Nationwide in FL, IA, IN, PA, NV, TX
The hazard
The hazard involves Level 3 masks produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Context
GovInfoNow's records show AMD Medicom Inc. has two other recalls on record since Oct. 11, 2019. On May 8, 2026, AMD Medicom recalled Ritmed Neurological Sponges due to an endotoxin risk in surgery. On Oct. 11, 2019, Medicom recalled Premier Plus Level 3 Masks because some level 2 masks may have been packed in level 3 mask boxes. Other recent recalls of similar products include New York Embroidery Studio Trinity Non-Surgical Isolation Gown Recall (July 31, 2026).
How to tell if you have this one
Check for item code 127-7573 on the mask packaging. The masks are blue and meet ASTM Level 3 standards. They were sold in lots 2339 and 2342.
Brand
PATTERSON PROCEDURE
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Look for item code 127-7573 on the mask packaging to confirm if it's part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Indiana, Iowa, Nevada, Pennsylvania, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1148-2024 (December 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1148-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.