Z-0605-2014Class II

VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH...

Name: Z-0605-2014 VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH...
Creator: Steris Corporation
Published: 2013-09-10
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-09-10 / Terminated / root cause: labeling and UDI

FDA source

Steris Corporation began a recall of VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine... on 2013-09-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0605-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-10
Posted: 2013-12-28
Terminated: 2014-02-14
Recalling firm: STERIS Corporation
Product: 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.
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.
Quantity in commerce: 1,238 boxes
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 codes and lots: Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0605-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0605-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-28

Product code FRC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)