Home › Device types › BYG
Mask, Oxygen
FDA product code BYG · Class 1 · Anesthesiology
1,099
Registered devices
470
Adverse events
41
Recalls
55
510(k) clearances
Devices with this code
AMSure® Oxygen Mask — AMSINO INTERNATIONAL, INC.N/A — SALTER LABSResp-O2 Oxygen Mask Medium-Concentration, Standard Adult — Dynarex CorporationEM — Allied Medical, LLCPuritan Bennett — Covidien LPHalyard — OWENS & MINOR DISTRIBUTION, INC.ACE — ACE SURGICAL SUPPLY CO., INC.ROSCOE — COMPASS HEALTH BRANDS CORP.Aerosol Masks — WESTMED, INC.Hi-oxygen mask adult non-rebreathing reservoir bag with 7ft Tube(universal conne — BESMED HEALTH BUSINESS CORP.Resp-O2 Oxygen Mask Medium-Concentration, Standard Infant — Dynarex CorporationHUDSON RCI — TELEFLEX INCORPORATEDResuscitation Face Mask Single Use Round Silicone Infant Size 1 — FLEXICARE MEDICAL LIMITEDN/A — SALTER LABSHUDSON RCI — TELEFLEX INCORPORATEDThe BAG™ Resuscitator - Adult model — Laerdal Medical ASROSCOE — COMPASS HEALTH BRANDS CORP.OxyMask™ II — Southmedic IncorporatedSENTRI INTERSURGICAL ECOLITE ADULT MASK WITH CO2 MONITORING LINE FILTER AND TUBE — Intersurgical Incorporated7301 EAGLE1 — HANS RUDOLPH, INC.Ventlab — VENTLAB, LLCCuraplex — TRI-ANIM HEALTH SERVICES, INC.ROSCOE — COMPASS HEALTH BRANDS CORP.Laerdal Silicone Masks — Laerdal Medical AS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-21 | Medline Industries, LP | Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may |
| 2018-07-11 | POM Medical LLC | Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a c |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The f |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc |
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