FDA recall record · openFDA

Steris Corporation

16 FDA recalls on record (2023–2025) — 16 device. 16 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of a 4

The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring 2

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Elec 2

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedur 2

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which cou 2

Recalls

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems Class II 2025-06-23 AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect Class II 2025-11-19 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems Class II 2025-06-23 AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfec Class II 2025-11-19 Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H Class II 2025-05-23 Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus Class II 2024-06-13 Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A Class II 2024-06-13 Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus Class II 2024-06-13 Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Class II 2024-06-13 V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intende Class II 2023-11-16 Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including di Class II 2023-03-17 Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 Class II 2023-12-12 Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Class II 2023-11-13 Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 Class II 2023-04-10 Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, sing Class II 2023-03-17 Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 Class II 2023-12-12

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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