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RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog… recallZ-0154-2027 · Steris Corporation · initiated Sep 21, 2026

Open, Classified All recalls posted in October 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Process change control

What the company is doing

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

Recall details

Recall number
Z-0154-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Sep 21, 2026
Posted by the FDA
Oct 14, 2026
Recalling firm
Steris Corporation
Quantity
374 units
Product code
FEB
FDA submissions
K082988
Distribution
Worldwide - US Nationwide distribution.

Product description

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115

Code information (models, lots, serial numbers)

UDI: 00724995245658 Lot numbers with expiration dates: 687046 10/5/2027 688017 10/19/2027

Other devices under the same FDA submission

4 devices cleared under K082988 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99804).

Sources and updates

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