Home › Device types › BTM
Ventilator, Emergency, Manual (Resuscitator)
FDA product code BTM · Class 2 · Anesthesiology
2,311
Registered devices
1,891
Adverse events
97
Recalls
209
510(k) clearances
Devices with this code
PremierPro — PRESTIGE AMERITECH, LTD.SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/SVentlab — VENTLAB, LLCVentlab — VENTLAB, LLCVital Signs™ — AIRLIFECuraplex — BOUND TREE MEDICAL, LLCSPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/SSINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O — BESMED HEALTH BUSINESS CORP.Ventlab — VENTLAB, LLCHALYARD — OWENS & MINOR DISTRIBUTION, INC.CPR Bag — MERCURY ENTERPRISES, INC.Vital Signs™ — AIRLIFEProcure — Twin Med, LLCHUDSON RCI — TELEFLEX INCORPORATEDAirLife™ — AIRLIFEVentlab — VENTLAB, LLCThe BAG™ Resuscitator - Adult model — Laerdal Medical ASVital Signs — Carefusion CorporationCPR-2 Bag — MERCURY ENTERPRISES, INC.Ventlab — VENTLAB, LLCCPR-2 Bag — MERCURY ENTERPRISES, INC.SINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF — BESMED HEALTH BUSINESS CORP.Vital Signs™ — AIRLIFECPR Bag — MERCURY ENTERPRISES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-08 | Datex-Ohmeda Inc | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the inten |
| 2025-07-09 | Ambu Inc. | Potential for the manometer port being blocked rendering the manometer non-functional. |
| 2025-05-01 | SunMed Holdings, LLC | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to pa |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma |
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