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ASP AEROFLEX™

ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Model 9119011 · UDI-DI 10705037064670

FEB
1
510(k) clearances
5,072
Adverse events (22 deaths)
43
Recalls
22
Facilities

Description

Leak Tester Connection Tube

Recalls

DateFirmReason
2026-09-21Steris CorporationIf 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
2026-09-21Steris CorporationIf 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
2026-09-21Steris CorporationIf 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
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasXXX
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

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Data 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.