RAPICIDE PA Part A High-Level Disinfectant recall (Steris Corporation)
Medical deviceClass IIOngoing
Summary: Steris Corporation is recalling RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115. 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.
What is being recalled
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution.
How to tell if yours is affected
UDI: 00724995245658 Lot numbers with expiration dates: 687046 10/5/2027 688017 10/19/2027
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0154-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 21, 2026 |
| Reported | October 21, 2026 |
| Company | Steris Corporation |
| Company location | Mentor, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 374 units |
More recalls from Steris Corporation · all medical device recalls · recalls from September 2026