FDAFDA recall Z-0075-2027 · Oct 14, 2026
Steris Corporation: VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 recall
Recall found
Product
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
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
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI:10724995023864 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
- Quantity
- 233
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- Steris Corporation, Mentor, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-31
Source: openFDA enforcement record Z-0075-2027 · search recall number Z-0075-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.