Lower riskMedical device recall · FDA · Published August 31, 2026
Steris VERIFY Steam Test Pack: Risk of False Sterilization Indicator
Steris recalls 217 units of VERIFY Biological Steam Test Pack model S3065 with lot numbers 260810, 260810A, 261106, 270116. These packs may show no growth during steam sterilization cycles, indicating a failed cycle when it's actually effective.
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
“Steris VERIFY Steam Test Pack: Risk of False Sterilization Indicator.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629444-steris-corporation-recalls-verify-biological-steam-test-pack-model-catalog. Based on FDA recall #Z-0074-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2027%22&limit=1).
The FDA announced on August 31, 2026, that Steris Corporation is recalling VERIFY Biological Steam Test Pack Model/S catalog number S3065. The biological indicator may show no growth even if the steam cycle was ineffective, posing a sterilization failure risk.
How to tell if you have it
Brand: Steris
Product: VERIFY Biological Steam Test Pack
Model/Catalog Number: S3065
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)
Distribution: Worldwide, including US Nationwide
The hazard
According to the FDA, the 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.
Context
GovInfoNow's records show Steris Corporation has 31 other recalls on record since June 15, 2017. Other recent recalls of similar products include Medline Surgical Packs Recall: Calibration Issues May Impact Sterility (January 7, 2026) and SPORETRAQ Mail-In Spore Testing Service Recall: Incorrect Incubation Process (April 13, 2026).
How to tell if you have this one
Check for model/catalog number S3065 on the pack. Lot numbers include 260810, 260810A, 261106, and 270116 with specific expiration dates.
Brand
Steris
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0070-2027
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006; UDI: 10724995220324 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
266
Z-0071-2027
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007; 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
409
Z-0072-2027
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060; UDI: 10724995023833 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 270302: expiration date - 03/02/2027
1185
Z-0073-2027
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061; UDI: 50724995023824 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 270302: expiration date - 03/02/2027
2205
Z-0074-2027
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065; 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
217
Z-0075-2027
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069; 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
233
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model number S3065 and lot numbers 260810, 260810A, 261106, or 270116 on the pack.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0074-2027 (August 31, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0074-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.