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20ga Diamond Coated Brush Polisher
KATALYST SURGICAL LLC · Model DV1002-20 · UDI-DI 00817489020982
0
510(k) clearances
2
Adverse events
3
Recalls
41
Facilities
Description
Box of 5, 20ga Diamond Coated Brush Polisher
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
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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.