Steris Corporation
7501 Page Ave, Saint Louis, MO, US
Registered product codes
5 product codes
Recent MDR events
3,320 on file
- STERIS 5095 Surgical TableJul 31, 2026Injury1043572-2026-00077
- ALYON Surgical Lighting SystemJul 31, 2026Malfunction1043572-2026-00078
- STERISJul 30, 2026Injury1043572-2026-00075
- S40 SterilantJul 30, 2026Injury3003950207-2026-00018
- 7080 Surgical TableJul 30, 2026Injury1043572-2026-00076
- HarmonyAIRJul 29, 2026Malfunction1043572-2026-00073
- ProlysticaJul 29, 2026Injury1937531-2026-00006
- NAJul 27, 2026Injury1043572-2026-00071
- AmscoJul 27, 2026Malfunction1043572-2026-00072
- Olympus Video Pediatric ColonoscopeJul 27, 2026Malfunction1527821-2026-00007
Recalls
133 on file
- Open, ClassifiedJun 15, 2026
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
View FDA record ↗ - Open, ClassifiedJun 15, 2026
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
View FDA record ↗ - Open, ClassifiedJun 15, 2026
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
View FDA record ↗ - Open, ClassifiedFeb 12, 2026
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
View FDA record ↗ - Open, ClassifiedDec 11, 2025
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
View FDA record ↗ - Open, ClassifiedDec 11, 2025
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
View FDA record ↗ - Open, ClassifiedJul 25, 2025
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
View FDA record ↗ - Open, ClassifiedJul 25, 2025
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
View FDA record ↗ - Open, ClassifiedAug 8, 2024
IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
View FDA record ↗ - Open, ClassifiedAug 8, 2024
IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
View FDA record ↗
Compliance history
Matched by FEI 1937531.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.