VERIFY recallZ-0779-2023 · Steris Corporation · initiated Dec 12, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
Steris issued Urgent Medical Device Recall letters to Customers and Distributors on 12/12/2022 via FedEX. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: [email protected] or via fax to (440) 392-8963. If you have questions regarding this recall, please contact Melissa Gonsalves, Senior Product Manager at (440) 392-7043, or STERIS Customer Service at 1-800-548-4873.
Recall details
- Recall number
- Z-0779-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 12, 2022
- Posted by the FDA
- Jan 3, 2023
- Recalling firm
- Steris Corporation
- Quantity
- 857 boxes
- Product code
- FRC
- FDA submissions
- K083665
- Distribution
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Product description
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
Code information (models, lots, serial numbers)
UDI: 10724995023833, 50724995023824 lot #230613
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VERIFY Dual SpeciesSteris Corporation · Indicator, biological sterilization process4 recalls1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91315).
- Z-0778-2023 · Open, ClassifiedVERIFY 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…
- Z-0780-2023 · Open, ClassifiedVERIFY 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 proce…
- Z-0781-2023 · Open, ClassifiedVERIFY 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 proc…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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