Z-0780-2023Class II

VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing...

Name: Z-0780-2023 VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing...
Creator: Steris Corporation
Published: 2022-12-12
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2022-12-12 / Open, Classified / root cause: manufacturing process

FDA source

Steris Corporation began a recall of VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide... on 2022-12-12. FDA classified it as Class II and gives the reason as "Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0780-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-12
Posted: 2023-01-03
Recalling firm: STERIS Corporation
Product: VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Steris issued Urgent Medical Device Recall letters to Customers and Distributors on 12/12/2022 via FedEX. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: [email protected] or via fax to (440) 392-8963. If you have questions regarding this recall, please contact Melissa Gonsalves, Senior Product Manager at (440) 392-7043, or STERIS Customer Service at 1-800-548-4873.
Quantity in commerce: 60 boxes
Distribution: Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Product codes and lots: UDI: 10724995023840 lot #230613

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0780-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0778-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-03
Z-0779-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-03
Z-0780-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-03
Z-0781-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)