Use cautionMedical device recall · FDA · Published September 21, 2026
Steris RAPICIDE PA Part A Disinfectant: Risk of Swelling and Exposure
Steris recalls 374 units of RAPICIDE PA Part A High-Level Disinfectant (model ML020115) due to potential swelling and chemical exposure if vented cap blocks, risking injury without proper PPE.
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.
“Steris RAPICIDE PA Part A Disinfectant: Risk of Swelling and Exposure.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764679-steris-corporation-recalls-rapicide-pa-part-a-high-level-disinfectant. Based on FDA recall #Z-0154-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0154-2027%22&limit=1).
The FDA announced on 2026-09-21 that Steris Corporation is voluntarily recalling RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number ML020115. The product may swell or leak due to blocked vents, posing an exposure risk to users.
How to tell if you have it
Brand: Steris Corporation
Product: RAPICIDE PA Part A High-Level Disinfectant
Model/Catalog Number: ML020115
UDI: 00724995245658
Lot numbers with expiration dates: 687046 10/5/2027, 688017 10/19/2027
Distribution: Worldwide - US Nationwide distribution
Units affected: 374
The hazard
According to the FDA, if the vented cap becomes blocked, gas may accumulate and cause the bottle to swell. In some cases, excess vapor or liquid chemistry may escape when the cap is twisted, which could result in user exposure if required personal protective equipment (PPE) is not properly used.
Context
GovInfoNow's records show Steris Corporation has 32 other recalls on record since 2017-06-15. Other recent recalls include Steris HexaVue Focus Integration System Software Issue May Cause Patient Info Mismatch (2026-09-23), Steris Corporation recalls VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060 (2026-08-31), and Steris ALYON Surgical Lighting System Recall: Buttons May Detach (2026-05-15). Other recent recalls of similar products include Boston Scientific EndoVive Safety PEG Kit Recall: Swabstick Packaging Risk (2026-02-10), Medline Convenience Kits Recall: Risk of Skin Infection from Open Seal Applicators (2026-07-20), and Medline Medical Kits Recall: Open Seal Risk in BD ChloraPrep Swabsticks (2025-12-24).
How to tell if you have this one
Check for the model/catalog number ML020115 on the product label. The affected units have lot numbers 687046 (expiring 10/5/2027) or 688017 (expiring 10/19/2027).
Brand
Steris Corporation
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0154-2027
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115; UDI: 00724995245658 Lot numbers with expiration dates: 687046 10/5/2027 688017 10/19/2027
374 units
Z-0155-2027
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116; UDI: 00724995245955 Lot numbers with expiration dates: 689171 5/4/2027 689981 5/12/2027 690993 5/26/2027 691739 6/2/2027 692570 6/11/2027 694357 7/1/2027
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0154-2027 (September 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0154-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.