Steris Corporation
FDA Regulatory Profile
Steris Corporation appears in FDA public data with 112 recalls, 205 510(k) clearances, 30 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2449-2026, Class II) was initiated on May 15, 2026. Its most recent 510(k) clearance was granted on June 24, 2026.
Summary
- Total Recalls
- 112
- 510(k) Clearances
- 205
- Inspections
- 30
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2449-2026 | Class II | HarmonyAIR A-Series Surgical Lighting System | May 15, 2026 |
| Z-2448-2026 | Class II | HarmonyAIR A-Series Surgical Lighting System | May 15, 2026 |
| Z-2450-2026 | Class II | ALYON Surgical Lighting System | May 15, 2026 |
| Z-0910-2026 | Class II | AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 70 | November 19, 2025 |
| Z-0909-2026 | Class II | AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 705 | November 19, 2025 |
| Z-2178-2025 | Class II | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems | June 23, 2025 |
| Z-2177-2025 | Class II | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems | June 23, 2025 |
| Z-1361-2026 | Class II | Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H | May 23, 2025 |
| Z-2539-2024 | Class II | Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface b | June 13, 2024 |
| Z-2537-2024 | Class II | Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface betwe | June 13, 2024 |
| Z-2538-2024 | Class II | Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface betwe | June 13, 2024 |
| Z-2536-2024 | Class II | Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between | June 13, 2024 |
| Z-0984-2024 | Class II | Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 | December 12, 2023 |
| Z-0983-2024 | Class II | Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 | December 12, 2023 |
| Z-0737-2024 | Class II | V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length | November 16, 2023 |
| Z-0617-2024 | Class II | Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endos | November 13, 2023 |
| Z-1595-2023 | Class II | Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 | April 10, 2023 |
| Z-1476-2023 | Class II | Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumabl | March 17, 2023 |
| Z-1475-2023 | Class II | Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle | March 17, 2023 |
| Z-0780-2023 | Class II | VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installa | December 12, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261055 | AMSCO 700 Steam Sterilizer | June 24, 2026 |
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | April 8, 2026 |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical St | April 8, 2026 |
| K252680 | Celerity 20 HP Biological Indicator | September 24, 2025 |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | May 2, 2025 |
| K243876 | VERIFY STEAM Integrating Indicator | April 25, 2025 |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | April 18, 2025 |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP B | February 6, 2025 |
| K250061 | Celerity Incubator | February 6, 2025 |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | December 4, 2024 |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | December 2, 2024 |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 400328 | November 8, 2024 |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | October 11, 2024 |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | September 17, 2024 |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | April 17, 2024 |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | March 6, 2024 |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | February 9, 2024 |
| K233681 | ConFirm 20 Minute Incubator | December 15, 2023 |
| K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | December 15, 2023 |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterila | October 3, 2023 |