Z-0073-2027

VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061

Name: Z-0073-2027 VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Creator: Steris Corporation
Published: 2026-08-31
License: https://open.fda.gov/license/

Steris Corporation / initiated 2026-08-31 / Open, Classified

FDA source

Recall record

Recall number: Z-0073-2027
Status: Open, Classified
Initiated: 2026-08-31
Posted: 2026-10-02
Recalling firm: Steris Corporation
Product: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
FDA root cause: Under Investigation by firm
Action: Firm began notifying customers on August 31, 2026 via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to destroy any affected product on hand. The firm will replace any product still within its shelf life.
Quantity in commerce: 2205
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI: 50724995023824 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027

Product code FRC

K083665Class IIVerify Scbi 275F 3-10STERIS Corporation / cleared 2009-09-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)