VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 recall (Steris Corporation)
Medical deviceClass IIOngoing
Summary: Steris Corporation is recalling VERIFY Biological Steam Test Pack Model/Catalog Number: S3065. Reason: 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.
What is being recalled
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Why
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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution.
How to tell if yours is affected
UDI: 10724995220300 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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0074-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 31, 2026 |
| Reported | October 14, 2026 |
| Company | Steris Corporation |
| Company location | Mentor, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 217 |
More recalls from Steris Corporation · all medical device recalls · recalls from August 2026