Rapicide PA High-Level Disinfectant recallZ-0156-2027 · Steris Corporation · initiated Sep 21, 2026

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-0156-2027

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

106758 units

Product code

FEB

FDA submissions

K082988

Distribution

Worldwide - US Nationwide distribution.

Product description

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Rapicide PA High-Level Disinfectant ML020117

  Medivators Inc. · Accessories, cleaning, for endoscope
  1 recall6 reports

Product lines

• Rapicide PA High-Level DisinfectantMedivators Inc. · 3 models · 80 reports · 1 recall

Other devices under the same FDA submission

3 devices cleared under K082988 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Advantage Plus Endoscope Reprocessing System 1-2-510.003

  Medivators Inc. · Accessories, Cleaning, For Endoscope
  98 reports
• Rapicide PA High-Level Disinfectant ML02-0117

  Medivators Inc. · Accessories, Cleaning, For Endoscope
  64 reports
• Rapicide PA High-Level Disinfectant ML02-0117

  Medivators Inc. · Accessories, Cleaning, For Endoscope
  10 reports

Other products in the same recall event

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

• Z-0154-2027 · Open, Classified
  RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
• Z-0155-2027 · Open, Classified
  RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116