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-0156-2027
- 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: ML020117
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: 00724995245962 Lot numbers with expiration dates: 688019 10/19/2027 688021 10/19/2027 688023 10/19/2027 688025 10/19/2027 688576 10/26/2027 688580 10/26/2027 688582 10/26/2027 688584 10/26/2027 688586 10/26/2027 688588 10/26/2027 689173 11/2/2027 689175 11/2/2027 689177 11/2/2027 689179 11/2/2027 689983 11/10/2027 689985 11/10/2027 689987 11/10/2027 690299 11/16/2027 690301 11/16/2027 690995 11/24/2027 690997 11/24/2027 690999 11/24/2027 691001 11/24/2027 691741 12/1/2027 691743 12/1/2027 691745 12/8/2027 692203 12/8/2027 692206 12/8/2027 692208 12/8/2027 692210 12/8/2027 692213 12/8/2027 692215 12/8/2027 692217 12/9/2027 692572 12/10/2027 692574 12/10/2027 692576 12/10/2027 692578 12/10/2027 692580 12/10/2027 692582 12/10/2027 692730 12/14/2027 692732 12/14/2027 692734 12/14/2027 692736 12/14/2027 692738 12/14/2027 692740 12/14/2027 692742 12/14/2027 692744 12/14/2027 694359 12/30/2027 694361 12/30/2027 694363 12/30/2027
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 |
Other Other Medical Devices recalls
All 13,929| 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 | NeuroStar Advanced Therapy System recalled by Neuronetics | Neuronetics | Other | Nationwide |
| Device | CLASS II | TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |