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Corporation Steris Canada · Model Acu-sInQ Leak Test · UDI-DI 00724995201807
10
510(k) clearances
5,046
Adverse events (22 deaths)
40
Recalls
22
Facilities
Description
The Karl Storz Leak Test Adapter is used with the Acu-sInQ Complete Endoscope Cleaning Aid System.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | XXX |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| 2026-03-25 | Olympus Corporation of the Americas | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
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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.