ATOS MEDICAL AB
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- Prosthesis, Laryngeal (Taub)Product code EWL (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.3730
Recalls & enforcement
- Class IITerminated2021-03-29Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “ATOS MEDICAL AB (FEI 3002806269) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806269-atos-medical-ab/
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