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HarmonyAIR
STERIS CORPORATION · Model Smoke Evacuator Remote Switch Activator · UDI-DI 00724995150129
10
510(k) clearances
721
Adverse events (5 deaths)
23
Recalls
73
Facilities
Description
The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR Smoke Evacuation System.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-16 | SurgiSmoke Solutions | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. |
| 2026-03-16 | SurgiSmoke Solutions | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. |
| 2026-03-16 | SurgiSmoke Solutions | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2015-07-20 | Stryker Instruments Div. of Stryker Corporation | The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak betwe |
| 2015-03-10 | Microtek Medical Inc | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain |
| 2015-03-10 | Microtek Medical Inc | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain |
| 2015-03-10 | Microtek Medical Inc | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain |
| 2015-03-10 | Microtek Medical Inc | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain |
| 2015-03-10 | Microtek Medical Inc | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain |
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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.