Steris recalls
18 official recalls and safety alerts involving Steris since 2022-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Steris or the relevant agency.
- 2026-10-14
USSteris Corporation recalls HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and…
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect…
FDA · DeviceSteris CorporationWorldwide - US Nationwide and the countries of Australia, Canada, New Zealand.Official notice →- US
Steris Corporation recalls VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological…
- 2026-06-24
- US
Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- US
Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
FDA · DeviceSteris CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2026-02-18
- US
Steris Corporation recalls 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.
FDA · DeviceSteris CorporationUS Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.Official notice → - 2025-12-17
- US
Steris Corporation recalls AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use…
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).
FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution in the states of Arizona, Colorado,…Official notice → - 2025-08-06
- US
Steris Corporation recalls 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…
FDA · DeviceSteris CorporationWorldwide - US Nationwide and Puerto Rico and the country of Canada.Official notice → - 2024-08-14
- US
Steris Corporation recalls Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" 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…
FDA · DeviceSteris CorporationWorldwide distribution - United States Nationwide and the countries of Canada,…Official notice → - 2024-02-14
- US
Steris Corporation recalls 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.
FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN,…Official notice → - 2024-01-24
- US
Steris Corporation recalls V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through…
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.
- 2024-01-03
- US
Steris Corporation recalls Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model…
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…
FDA · DeviceSteris CorporationDomestic distribution nationwide. Foreign distribution to Australia Canada…Official notice → - 2023-05-24
- US
Steris Corporation recalls Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could…
FDA · DeviceSteris CorporationWorldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of:…Official notice → - 2023-05-10
- US
Steris Corporation recalls Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical…
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution including Puerto Rico and the countries…Official notice → - 2023-01-11
- US
Steris Corporation recalls VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of…
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others…
FDA · DeviceSteris CorporationNationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZAOfficial notice → - 2022-11-23
- US
Steris Corporation recalls GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or…
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which…
FDA · DeviceSteris CorporationUS Nationwide distribution in the states of Arizona, Illinois, Tennessee,…Official notice → - 2022-10-19
- US
Steris Corporation recalls Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking…
FDA · DeviceSteris CorporationDistribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan,…Official notice → - 2022-06-15
- US
Steris Corporation recalls Reliance Synergy Washer/Disinfector
The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke…
- 2022-06-01
- US
Steris Corporation recalls 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 Number: ENC100
Product not approved for release for US distribution