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Steris Corporation FDA Recalls
29 recalls on file across devices, 0 of them Class I and 23 still open. Matched by name to STE.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| HarmonyAIR A-Series Surgical Lighting SystemClass IIMay 15, 2026There is a potential for paint delamination (chipping/peelin |
| HarmonyAIR A-Series Surgical Lighting SystemClass IIMay 15, 2026The the plus and minus buttons (+/-) used to control light i |
| ALYON Surgical Lighting SystemClass IIMay 15, 2026The the plus and minus buttons (+/-) used to control light i |
| AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/DisinfecClass IINov 19, 2025Wire connected to the electrical box may shift out of its in |
| AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/DisinfectClass IINov 19, 2025Wire connected to the electrical box may shift out of its in |
| Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting SystemsClass IIJun 23, 2025The DFPM yoke assembly ("yoke assembly") may detach from the |
| Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting SystemsClass IIJun 23, 2025The DFPM yoke assembly ("yoke assembly") may detach from the |
| Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-HClass IIMay 23, 2025This is a sub-recall of event RES 96885. The supplier identi |
| Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage PlusClass IIJun 13, 2024IFU for hookup were incorrectly reflected within hookup IFUs |
| Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD AutomatedClass IIJun 13, 2024IFU for hookup were incorrectly reflected within hookup IFUs |
| Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage PlusClass IIJun 13, 2024IFU for hookup were incorrectly reflected within hookup IFUs |
| Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" AClass IIJun 13, 2024IFU for hookup were incorrectly reflected within hookup IFUs |
| Dual Articulating Headrest, Velcro P/N P141210813, REF BF753Class IIDec 12, 2023Dual-articulating head rest may not stay in place or may fai |
| Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754Class IIDec 12, 2023Dual-articulating head rest may not stay in place or may fai |
| V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- IntendeClass IINov 16, 2023Bandage Scissors handle cover component contains an incorrec |
| Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Class IINov 13, 2023Identification label on affected hookups could become illegi |
| Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062Class IIApr 10, 2023In the remote occurrence in which the electrical contactor c |
| Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including diClass IIMar 17, 2023Light handle covers may separate from the light handle (deta |
| Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, singClass IIMar 17, 2023Light handle covers may separate from the light handle (deta |
| VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installaClass IIDec 12, 2022Biological indicator (BI) used to promote growth of the G. s |
| VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installClass IIDec 12, 2022Biological indicator (BI) used to promote growth of the G. s |
| VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and roClass IIDec 12, 2022Biological indicator (BI) used to promote growth of the G. s |
| VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and rouClass IIDec 12, 2022Biological indicator (BI) used to promote growth of the G. s |
| GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagClass IIOct 17, 2022Two electronic diode components (D1 & D4) placed in the reve |
| Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360Class IISep 2, 2022The scalpel holder may separate from the handle for certain |
| Reliance Synergy Washer/DisinfectorClass IIApr 22, 2022The firm identified that when the electrical contactor compo |
| Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model NumClass IIMar 22, 2022Product not approved for release for US distribution |
| Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm MoClass IIMar 22, 2022Product not approved for release for US distribution |
| OT1000 Series Orthopedic Surgical TablesClass IIJan 21, 2021On January 7, 2021, STERIS identified that the glued bond be |