Home › AMBLER SURGICAL CORP. › Ambler Surgical
Ambler Surgical
AMBLER SURGICAL CORP. · Model Akahoshi MICS capsule polisher I/A tip · UDI-DI 00190660087616
MXY
Prescription
0
510(k) clearances
2
Adverse events
3
Recalls
41
Facilities
Description
Akahoshi MICS capsule polisher I/A tip, 22 gauge, curved, 1.1mm sandblasted ball tip, 45 degrees angled 0.3mm port, screw-in
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.