CLASS II ONGOING Device recall · Reported 11 Jan 2023 · FDA Enforcement Report
Verify Steam Test Pack (20 Tests and 20 controls) recalled by Steris
Steris is recalling Verify Steam Test Pack (20 Tests and 20 controls), distributed nationwide in the US. The recall was initiated on 12 Dec 2022 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-0781-2023
- FDA event ID
- 91315
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2022
- FDA classified
- 3 Jan 2023
- Reported
- 11 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 12 Dec 2022 | Recall initiated by company | |
| 3 Jan 2023 | Classified by FDA | +22 days |
| 11 Jan 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Where it was distributed
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Questions about this recall
Why was it recalled?
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
Which lots are affected?
UDI: 10724995023864 lot #230613
Where was it sold?
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
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 26 Sep 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
3 other products · FDA event 91315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Verify Dual Species Self-Contained Biological Indicators recalled | Steris | Sterility | Nationwide | |
| CLASS II | Verify Steam Test Pack (20 Tests and 5 controls) recalled by Steris | Steris | Sterility | Nationwide | |
| CLASS II | Verify Dual Species Self-Contained Biological Indicators recalled | Steris | Sterility | Nationwide |
More recalls from Steris
All 120| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Verify Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide |
| Device | CLASS II | Verify Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |