Home › Device types › BTM
Ventilator, Emergency, Manual (Resuscitator)
FDA product code BTM · Class 2 · Anesthesiology
2,311
Registered devices
1,902
Adverse events
97
Recalls
209
510(k) clearances
Devices with this code
Ventlab — VENTLAB, LLCVital Signs™ — AIRLIFESPUR® II Adult ResuscitatorSingle Patient Use Resuscitator — Ambu A/SAirFlow — VENTLAB, LLCSILICONE ADULT 1600ML RESUSCITATOR W/O POP-OFF , L TYPE ADAPTER — BESMED HEALTH BUSINESS CORP.LIFESAVER — GaleMed Xiamen Co., Ltd.Ventlab — VENTLAB, LLCCPR-2 Bag — MERCURY ENTERPRISES, INC.NP 1000-2D O2 Instant Flow Valve Bag Hanger — INSTRUMENTATION INDUSTRIES, INCORPORATEDLSR Adult Standard w/Masks in Carton — Laerdal Medical ASCPR-2 Bag — MERCURY ENTERPRISES, INC.Ventlab — VENTLAB, LLCCPR-2 Bag — MERCURY ENTERPRISES, INC.mada — ENTER MEDICAL CORPORATIONMedline — MEDLINE INDUSTRIES, INC.CPR-2 Bag — MERCURY ENTERPRISES, INC.butterflyBVM READY — Compact Medical Inc.SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator — Ambu A/SMark IV Resuscitatorwith single shutter patient valve — Ambu A/SVentlab — VENTLAB, LLCAirLife — Carefusion CorporationVentlab — VENTLAB, LLCCPR Bag Reusable — MERCURY ENTERPRISES, INC.Life Support Products (LSP) — Allied Medical, LLC
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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