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VERIFY
STERIS CORPORATION · Model S3070 · UDI-DI 10724995023871
1
510(k) clearances
1,469
Adverse events
46
Recalls
42
Facilities
Description
The VERIFY Disposable Biological EO Test Packs are for use in monitoring healthcare ethylene oxide (EO) sterilization processes. Each test pack contains 20 Packs with 5 Controls.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-04-13 | HF Acquisition Co LLC | Due to incorrect incubation process being performed on product. |
| 2026-04-13 | HF Acquisition Co LLC | Due to incorrect incubation process being performed on product. |
| 2025-01-15 | TERRAGENE S.A. | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. |
| 2024-12-11 | HF Acquisition Co LLC | Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results t |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.