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STRYKER CORPORATION · Model 0700034000 · UDI-DI 07613154116355
FYD
Prescription
10
510(k) clearances
720
Adverse events (5 deaths)
23
Recalls
73
Facilities
Description
Fluid Suction HEPA Filter
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.