Surgicot Steam Test Pack

510(k) K854902

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK854902	Date20 May 1986Cleared	StatusActive

6 recalls · 5 ongoing · FDA

4 recalls, same reason
- Ongoing Z-0074-2027 FDA Class II initiated 31 Aug 2026
- Ongoing Z-0071-2027 FDA Class II initiated 31 Aug 2026
- Ongoing Z-0070-2027 FDA Class II initiated 31 Aug 2026
- Ongoing Z-0075-2027 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
- Ongoing Z-1793-2022 FDA Class III initiated 25 May 2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)