FDA-Device2026-10-21Class IIPACKAGING DEFECT

Steris RAPICIDE PA Part A High-Level Disinfectant recalled for blocked vent cap pressure hazard

Nationwide distributionMedical devices

What this means

The vented cap on Steris RAPICIDE PA Part A High-Level Disinfectant bottles (Model ML020117) may become blocked, causing gas to accumulate inside. This can lead to bottle swelling and pressure buildup. When the cap is opened, excess vapor or liquid disinfectant may escape suddenly, potentially exposing users to the chemical if proper personal protective equipment is not worn.

  • Check if you have RAPICIDE PA Part A bottles with lot numbers and expiration dates listed in the recall (ranging from 10/19/2027 to 12/30/2027).
  • Inspect the vent cap for any blockage before opening bottles already in use.
  • Always wear required personal protective equipment when handling this disinfectant.
  • Contact Steris Corporation or the FDA for instructions on return or disposal of affected bottles.
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
106758 units
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0156-2027

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