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VERIFY Dual Species

by Steris Corporation

VERIFY Dual Species (S306) is a Class II device made by Steris Corporation, cleared under FDA 510(k) K083665 on 1 Sep 2009 (3 earlier submissions) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 10724995023833), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10724995023833 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK083665 Date1 Sep 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083665 decided 1 Sep 2009 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10724995023833 listed 9 Sep 2016 Listed

Recalls

7 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0073-2027 FDA Class II initiated 31 Aug 2026
    • Ongoing Z-0072-2027 FDA Class II initiated 31 Aug 2026

    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

  • 4 recalls, same reason

    • Ongoing Z-0780-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-0781-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-0779-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-0778-2023 FDA Class II initiated 12 Dec 2022

    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.

    • Terminated Z-0605-2014 FDA Class II initiated 10 Sep 2013

    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.

Timeline

12 dated events

  1. Cleared FDA 510(k) K051056
  2. Cleared FDA 510(k) K083665
  3. Recall initiated FDA recalls Z-0605-2014
  4. Listed FDA GUDID 10724995023833
  5. Recall initiated FDA recalls Z-0780-2023
  6. Recall initiated FDA recalls Z-0781-2023
  7. Recall initiated FDA recalls Z-0779-2023
  8. Recall initiated FDA recalls Z-0778-2023
  9. Recall initiated FDA recalls Z-0073-2027
  10. Recall initiated FDA recalls Z-0072-2027

2 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Verify
Generic name
Biological sterilization indicator
Model / Ref / Catalog
Dual Species, S306
Primary DI / UDI-DI
10724995023833
510(k) Number
FDA product code
FRC
GMDN term
Biological sterilization indicator
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Biological sterilization indicator

Cleared under the same submission (K083665)

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)