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FDA recall, , Moderate risk

Steris Rapicide PA Part A High-Level Disinfectant

Rapicide PA Part A High-Level Disinfectant may swell if its vented cap is blocked, and could expose users to vapor or liquid.

What happened

Steris Corporation recalled Rapicide PA Part A High-Level Disinfectant on September 21, 2026, because 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. The recall was added to the FDA's Enforcement Report on October 14, 2026, with worldwide - US nationwide distribution.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Match your product and all the details in one listed combination.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Rapicide PA Part A High-Level Disinfectant, Model/

    1. UDI-DI
      • 00724995245658
      Catalog code
      • ML020115
    2. UDI-DI
      • 00724995245962
      Catalog code
      • ML020117
    3. UDI-DI
      • 00724995245955
      Catalog code
      • ML020116

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide distribution.

Company
Steris Corporation
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99804
Recall numbers
Z-0154-2027 to Z-0156-2027

All recalls from Steris Corporation

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

Summary by Recall Canary, written with AI · summary updated Oct 15, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)