CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Rapicide PA Part A High-Level Disinfectant recalled by Steris
Steris is recalling Rapicide PA Part A High-Level Disinfectant, distributed nationwide in the US. The recall was initiated on 21 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0155-2027
- FDA event ID
- 99804
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Sep 2026
- FDA classified
- 14 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Sep 2026 | Recall initiated by company | |
| 14 Oct 2026 | Classified by FDA | +23 days |
| 21 Oct 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99804This product is part of a recall event; the main page for the event is Rapicide PA Part A High-Level Disinfectant recalled by Steris.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide | |
| CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide |
More recalls from Steris
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide |
| Device | CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide |
| Device | CLASS II | Verify Biological Steam Test Pack recalled by Steris | Steris | Sterility | Nationwide |
| Device | CLASS II | HexaVue Focus Integration System, a single recalled by Steris | Steris | Device Malfunction | Nationwide |
| Device | CLASS II | Verify Biological/Integrator Challenge Pack recalled by Steris | Steris | Sterility | Nationwide |
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