CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Verify Biological/Integrator Challenge Pack recalled by Steris
Steris is recalling Verify Biological/Integrator Challenge Pack, distributed nationwide in the US. The recall was initiated on 31 Aug 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-0071-2027
- FDA event ID
- 99704
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2026
- FDA classified
- 2 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2026 | Recall initiated by company | |
| 2 Oct 2026 | Classified by FDA | +32 days |
| 14 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
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 Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Which lots are affected?
UDI: 10724995220331 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027
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 21 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
5 other products · FDA event 99704This product is part of a recall event; the main page for the event is Verify Biological Steam Test Pack recalled by Steris.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Verify Biological Steam Test Pack recalled by Steris | Steris | Sterility | Nationwide | |
| CLASS II | Verify Biological/Integrator Challenge Pack recalled by Steris | Steris | Sterility | Nationwide | |
| CLASS II | Verify Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide | |
| CLASS II | Verify Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide | |
| CLASS II | Verify Biological Steam Test Pack recalled by Steris | 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 Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide |
| Device | CLASS II | Verify Dual Species Self-Contained Biological Indicator recalled | Steris | Sterility | Nationwide |
| Device | CLASS II | Verify Biological/Integrator Challenge Pack recalled by Steris | Steris | Sterility | Nationwide |
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