Steris Corporation Recalls
13 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (13)
- Class II
November 19, 2025
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of s
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).
- Class II
November 19, 2025
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of so
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).
- Class II
June 23, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
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.
- Class II
June 23, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
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.
- Class II
May 23, 2025
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
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.
- Class II
June 13, 2024
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids
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
- Class II
June 13, 2024
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endosc
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
- Class II
June 13, 2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope
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
- Class II
June 13, 2024
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endosc
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
- Class II
December 12, 2023
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
- Class II
December 12, 2023
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
- Class II
November 16, 2023
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001
Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.
- Class II
November 13, 2023
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP
Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.