FDA Device recall Z-0074-2027
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 by Steris, citing geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potentia….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0074-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-31 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Steris |
| Distribution | US |
Product
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Reason
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
Identifiers
| code_info | UDI: 10724995220300 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: exp…UDI: 10724995220300 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Steris
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
FDA Device · Class II · 2026-10-21 · Steris - RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
FDA Device · Class II · 2026-10-21 · Steris - RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
FDA Device · Class II · 2026-10-21 · Steris - VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
FDA Device · Class II · 2026-10-14 · Steris - VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
FDA Device · Class II · 2026-10-14 · Steris
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.