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MEDLINE INDUSTRIES, INC. · Model HARH36R · UDI-DI 10193489081329
NLQ
Prescription
1
510(k) clearances
985
Adverse events (3 deaths)
7
Recalls
12
Facilities
Description
HARMONIC ACE+7 SHEARS 5MM X 36CM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-24 | Stryker Sustainability Solutions | Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. |
| 2024-05-07 | MEDLINE INDUSTRIES, LP - Northfield | Potential for an incomplete seal on the packaging tray. |
| 2023-08-03 | MEDLINE INDUSTRIES, LP - Northfield | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
| 2021-01-19 | Stryker Sustainability Solutions | Product was distributed without receiving regulatory clearance. |
| 2018-05-08 | Stryker Sustainability Solutions | Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
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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.