Z-0155-2027

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

Name: Z-0155-2027 RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Creator: Steris Corporation
Published: 2026-09-21
License: https://open.fda.gov/license/

Steris Corporation / initiated 2026-09-21 / Open, Classified

FDA source

Recall record

Recall number: Z-0155-2027
Status: Open, Classified
Initiated: 2026-09-21
Posted: 2026-10-14
Recalling firm: Steris Corporation
Product: RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Product code: FEB Accessories, Cleaning, For Endoscope
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 root cause: Process change control
Action: An 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 [email protected], 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 commerce: 11806 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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

Product code FEB

K082988Class IIMedivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level DisinfectantMedivators Reprocessing Systems / cleared 2009-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-16. View this recall on fda.gov (opens on fda.gov)