Lower riskMedical device recall · FDA · Published December 12, 2022
Steris VERIFY Steam Test Pack Recall: Inconsistent Biological Indicator Risk
Steris recalls VERIFY Steam Test Pack (20 Tests) due to inconsistent biological indicator growth. This could lead to false indication of sterilization effectiveness, risking infection. Affected units have item number S3069 and lot #230613.
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.
“Steris VERIFY Steam Test Pack Recall: Inconsistent Biological Indicator Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59166-steris-verify-steam-test-pack-recall-inconsistent-biological-indicator-risk. Based on FDA recall #Z-0781-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0781-2023%22&limit=1).
The FDA announced on Dec. 12, 2022, that Steris Corporation is recalling VERIFY Steam Test Pack (Item Number S3069) due to inconsistent biological indicators. The agency said the defect could falsely indicate sterilization cycles were effective when they may not have been.
How to tell if you have it
Brand: Steris
Product: VERIFY Steam Test Pack (20 Tests and 20 controls)
Item Number: S3069
Lot code: #230613
Units affected: 105 boxes
The hazard
According to the FDA, the biological indicator used to promote growth of G. stearothermophilus and B. atrophaeus spores was inconsistent throughout the lot. Some indicators performed as intended while others did not, potentially showing no growth even if a sterilization cycle was ineffective.
Context
GovInfoNow's records show Steris Corporation has 29 other recalls on record since June 15, 2017. Recent recalls include the May 15, 2026 Steris HarmonyAIR A-Series Surgical Lights recall for detaching buttons and paint delamination, and the Nov. 19, 2025 AMSCO 7052HP Washer/Disinfector recall for electrical arcing risk. Other recent recalls of similar products include Medline Convenience Kits Recall (Jan. 7, 2026), Medline Surgical Packs Recall (Jan. 7, 2026), and another Medline Surgical Packs Recall (Jan. 7, 2026).
How to tell if you have this one
Check for item number S3069 and lot number 230613 on the package. The product is intended for use in healthcare sterilization testing.
Brand
Steris
Category
Medical device
FDA recall event · 4 products
All 4 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
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Recall number
Product, codes & lots
Quantity
Z-0778-2023
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes; UDI: 10724995023833 lot #230613
338 boxes
Z-0779-2023
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes; UDI: 10724995023833, 50724995023824 lot #230613
857 boxes
Z-0780-2023
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes; UDI: 10724995023840 lot #230613
60 boxes
Z-0781-2023
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; UDI: 10724995023864 lot #230613
105 boxes
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for item number S3069 and lot number 230613 on the package.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA” 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 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0781-2023 (December 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0781-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.