Steris SAS
Inactive in EUDAMED since 2026Francefrom EUDAMED address EUDAMED SRN FR-MF-000011548
Inactive. This company's EUDAMED actor record is marked inactive. Check the current status before ordering.
- Devices
- 0
- Registrations
- EUDAMED
- FDA recalls
- 1313 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
Company details
- EUDAMED SRN
- FR-MF-000011548
- EU VAT number
- FR 87 391 461 373
- EUDAMED status
- Inactive since 2026
- EUDAMED registered name
- STERIS SAS
- EUDAMED abbreviated name
- STERIS
- Address
- 5960 Heisley Road, 44060 Mentor, OH, US
- Website
- www.steris.com
- facebook.com/steriscorporate
- [email protected]
- PRRC contact
- Marlene Freyssac
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 13
2026
- 23 Sep 2026 Z-0118-2027 Class II Ongoing A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
- 21 Sep 2026 Z-0154-2027 Class II Ongoing If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
- 21 Sep 2026 Z-0155-2027 Class II Ongoing If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
- 21 Sep 2026 Z-0156-2027 Class II Ongoing If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
- 31 Aug 2026 Z-0070-2027 Class II Ongoing 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
- 31 Aug 2026 Z-0071-2027 Class II Ongoing 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
- 31 Aug 2026 Z-0072-2027 Class II Ongoing 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
- 31 Aug 2026 Z-0073-2027 Class II Ongoing 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
- 31 Aug 2026 Z-0074-2027 Class II Ongoing 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
- 31 Aug 2026 Z-0075-2027 Class II Ongoing 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
Show all 13 recalls
2026
- 15 May 2026 Z-2448-2026 Class II Ongoing There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
- 15 May 2026 Z-2449-2026 Class II Ongoing The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- 15 May 2026 Z-2450-2026 Class II Ongoing The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
From the company website
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.