The Recall Desk
ModerateFDA (Devices)·Z-0605-2014·Announced 2014-01-08

Steris Recalls Verify Dual Species Biological Indicators Due to Spore Count Defect

Steris is recalling Verify Dual Species Self-Contained Biological Indicators because the spore count is lower than labeled, potentially causing false sterilization results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for false sterilization results rather than a direct physical injury, fitting the criteria for a moderate severity score.

Plain-English summary

Steris Corporation is recalling 1,238 boxes of Verify Dual Species Self-Contained Biological Indicators, Lot #131004. The affected models are S3060, S3061, S3065, S3069, LCB006, and LCB007. These products are intended for installation testing and routine monitoring of steam and ethylene oxide sterilization processes.

The recall was initiated because the population of G. stearothermophilus spores used to monitor steam sterilization cycles does not meet specifications. The spore count on the affected product is lower than the labeled minimum, which may cause the product to incorrectly indicate that a 5-log spore kill was achieved.

The affected units were distributed worldwide, including nationwide in the United States and in Bahrain, Canada, Colombia, Germany, Italy, Malaysia, the Philippines, Romania, Spain, and the Netherlands. Users should check their inventory for Lot #131004 and contact Steris Corporation for further instructions.

The recalled product

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.
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Monitoring
Hazard
Affected units
1,238

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot #131004 Model #'s: S3060
  • S3061
  • S3065
  • S3069
  • LCB006 & LCB007.

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Related recalls

Same manufacturer · Steris Corporation

See all →