FDA-Device2026-10-21Class IIPACKAGING DEFECT

Steris RAPICIDE PA Part A High-Level Disinfectant recalled for blocked vent cap and chemical exposure risk

Nationwide distributionMedical devices

What this means

The vented cap on Steris RAPICIDE PA Part A High-Level Disinfectant bottles can become blocked, causing gas to build up inside. When the cap is opened, excess vapor or liquid may escape and expose users to the chemical if proper personal protective equipment is not worn.

  • Check if you have lot numbers 689171, 689981, 690993, 691739, 692570, or 694357 with expiration dates between 5/4/2027 and 7/1/2027.
  • Ensure the vent hole in the cap is clear before opening the bottle.
  • Always wear required personal protective equipment (gloves, eye protection, respiratory protection) when handling this product.
  • Contact Steris Corporation for instructions on returning or replacing 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
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
11806 units
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0155-2027

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