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U.S. Department of Health and Human Services

Class 2 Device Recall RAPICIDE PA Part A HighLevel Disinfectant

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 Class 2 Device Recall RAPICIDE PA Part A HighLevel Disinfectantsee related information
Date Initiated by FirmSeptember 21, 2026
Date PostedOctober 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0156-2027
Recall Event ID 99804
510(K)NumberK082988 
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
ProductRAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Code Information UDI: 00724995245962 Lot numbers with expiration dates: 688019 10/19/2027 688021 10/19/2027 688023 10/19/2027 688025 10/19/2027 688576 10/26/2027 688580 10/26/2027 688582 10/26/2027 688584 10/26/2027 688586 10/26/2027 688588 10/26/2027 689173 11/2/2027 689175 11/2/2027 689177 11/2/2027 689179 11/2/2027 689983 11/10/2027 689985 11/10/2027 689987 11/10/2027 690299 11/16/2027 690301 11/16/2027 690995 11/24/2027 690997 11/24/2027 690999 11/24/2027 691001 11/24/2027 691741 12/1/2027 691743 12/1/2027 691745 12/8/2027 692203 12/8/2027 692206 12/8/2027 692208 12/8/2027 692210 12/8/2027 692213 12/8/2027 692215 12/8/2027 692217 12/9/2027 692572 12/10/2027 692574 12/10/2027 692576 12/10/2027 692578 12/10/2027 692580 12/10/2027 692582 12/10/2027 692730 12/14/2027 692732 12/14/2027 692734 12/14/2027 692736 12/14/2027 692738 12/14/2027 692740 12/14/2027 692742 12/14/2027 692744 12/14/2027 694359 12/30/2027 694361 12/30/2027 694363 12/30/2027
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactMichelle LaVan
440-2597417
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 9/8/26 was sent to customers. User Action Users can continue using the RAPICIDE product through the remainder of its shelf life. Please immediately inspect your on-hand inventory for product affected by this recall. If bottle bulging is observed, follow the instructions below to release any accumulated pressure and dispose of the product: 1. Users MUST wear personal protective equipment (PPE) before handling the bottle, including: a. Safety eyewear b. Chemical-resistant gloves c. A solvent-resistant apron d. Protective footwear appropriate for chemical handling 2. Move the product to an appropriate, well-ventilated area. Respiratory protection is also recommended in accordance with the RAPICIDE PA Part A Safety Data Sheet (SDS). Refer to Attachment C to this letter for an excerpt of the SDS. 3. Carefully loosen the cap. Slowly begin untwisting the cap while keeping the threads engaged to allow any accumulated pressure to release gradually. 4. Allow the pressure to vent. Continue loosening the cap slowly over approximately 1 to 2 minutes until the pressure has been released and the cap can be fully removed. 5. Dispose of the bottle and contents through your facility's hazardous or special waste program in accordance with applicable local, regional, national, and/or international regulations. Do not replace the cap on a bottle that has exhibited bulging. 6. Please complete the Recall Response Form included with this letter, and return via email to Regulatory_Compliance@STERIS.com, or via fax to 440-392-8963. Replacement product will be provided for any product that had to be disposed. Users are also reminded to report any adverse events via FDA s MedWatch Database or local competent authority should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please co
Quantity in Commerce106758 units
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FEB
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