RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Summary
The FDA issued a Class II for RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 by Steris Corporation. 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 liq.
Details
Source
Device Recall
External ID
Z-0155-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Lot/Code Info: UDI: 00724995245955 Lot numbers with expiration dates: 689171 5/4/2027 689981 5/12/2027 690993 5/26/2027 691739 6/2/2027 692570 6/11/2027 694357 7/1/2027
Quantity Affected: 11806 units
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-21
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Steris Corporation has 79 FDA actions in our database, including 38 recalls and 41 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 79 FDA actions in our database, including 38 recalls and 41 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0155-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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