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PENTAX OF AMERICA, INC. · Model 848102 · UDI-DI 04961333241576
FEB
Prescription
1
510(k) clearances
5,104
Adverse events (22 deaths)
43
Recalls
23
Facilities
Description
CHANNEL CONNECTOR TUBE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-21 | Steris Corporation | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from |
| 2026-09-21 | Steris Corporation | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from |
| 2026-09-21 | Steris Corporation | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from |
| 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. |
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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.