Recall Z-0155-2027— Steris Corporation

Name: FDA recall Z-0155-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-21

Class II · Ongoing

Class II FDA medical device recall by Steris Corporation, initiated 2026-09-21. It names one FDA 510(k) clearance: K082988. Product: RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116. Reason: 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 the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity..

Recalling firm: Steris Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-09-21
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K082988 — MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANTMedivators Reprocessing Systems·cleared 2009-02-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116

Reason for recall

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 the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

Data sourced from openFDA. This site is unofficial and independent of the FDA.