FDA recalls Steris RAPICIDE PA disinfectant
Steris is recalling 11,806 units of its RAPICIDE PA high-level disinfectant because a blocked vented cap can cause the bottle to swell and release vapor or liquid, risking user injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The hazard named in the source is injury from escaped vapor or liquid when the vented cap is opened without proper protective equipment. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
The U.S. Food and Drug Administration has recalled RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number ML020116, manufactured by Steris Corporation. The recall covers approximately 11,806 units distributed worldwide, including nationwide in the United States. The issue involves the vented cap on the bottle: if it becomes blocked, gas may accumulate inside the bottle and cause it to 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 is not properly used. Such exposure may result in injury to the user or others in close proximity.
Consumers who hold affected product should stop using it immediately and contact Steris Corporation for guidance on return or replacement. Affected lot numbers include 689171 (expiration 5/4/2027), 689981 (5/12/2027), 690993 (5/26/2027), 691739 (6/2/2027), 692570 (6/11/2027), and 694357 (7/1/2027).
No illnesses, injuries, or deaths have been reported in connection with this recall. The FDA classified this recall as Class II, meaning use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
- Manufacturer
- Steris Corporation
- Affected units
- 11,806
Distribution
Distributed nationwide across the United States.
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