VERIFY Dual Species Self-Contained Biological Indicator… recallZ-0605-2014 · Steris Corporation · initiated Sep 10, 2013
Class II Terminated All recalls posted in December 2013
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
STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.
FDA root cause category: Use error
What the company is doing
On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.
Recall details
- Recall number
- Z-0605-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 10, 2013
- Posted by the FDA
- Dec 28, 2013
- Recalling firm
- Steris Corporation
- Quantity
- 1,238 boxes
- Product code
- FRC
- FDA submissions
- K083665, K854631, K854902
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY, and the countries of BAHRAIN, CANADA, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and THE NETHERLANDS.
Product description
VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
Code information (models, lots, serial numbers)
Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.
Other devices under the same FDA submission
3 devices cleared under K083665, K854631, K854902 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VERIFY S3065Steris Corporation · Indicator, biological sterilization process1 recall0 reports
- VERIFY LCB006Steris Corporation · Indicator, biological sterilization process1 recall0 reports
- VERIFY LCB007Steris Corporation · Indicator, biological sterilization process1 recall0 reports
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 18, 2026. Text above is shown as published by the FDA.
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