SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator
Ambu A/S · Model 520611600 · UDI-DI 05707480032983
BTM
Prescription
10
510(k) clearances
1,891
Adverse events (164 deaths)
97
Recalls
74
Facilities
Description
Ambu SPUR II Adult with closed reservoir, with Duraclear face mask size medium adult and with Tube Check bulb. 6 pcs/box
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 intended concentration se |
| 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 patient use, there wou |
| 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 may cause improper ven |
| 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 may cause improper ven |
| 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 may cause improper ven |
| 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 may cause improper ven |
| 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 may cause improper ven |
| 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 may cause improper ven |
| 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 may cause improper ven |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.