VERIFY¿ Dual Species Self-Contained Biological Indicator — Class II medical device recall Z-0605-2014

Terminated recall by Steris Corporation, reported 2014-01-08, distributed nationwide. STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization

Recall number	`Z-0605-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Steris Corporation, Mentor, OH, United States
Recall initiated	2013-09-10
Classified	2013-12-28
Reported by FDA	2014-01-08
Terminated	2014-02-14
Distributed	Nationwide (US)
Countries outside the US	BH, CA, DE, ES, IT, MY, NL, PH, RO
Quantity	1,238 boxes
Reason classes	labeling
Lot numbers	`131004`
Model numbers	`LCB006`, `LCB007`, `S3060`, `S3061`, `S3065`, `S3069`

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0605-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.