Recall archive
54 recalls · page 1 of 3
Reported Oct 21, 2026Updated Oct 26, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or…
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
HarmonyAIR A-Series Surgical Lighting System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — 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)…
FDA (openFDA device enforcement)
Reported Dec 17, 2025
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the…
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from…
FDA (openFDA device enforcement)
Reported May 24, 2023
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber…
FDA (openFDA device enforcement)
Reported May 10, 2023
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 11, 2023
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature…
FDA (openFDA device enforcement)
Reported Oct 19, 2022
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Steris Corporation Hopkins Facility
Matched: Brand — Product contains incorrect chemical indicators in packaging.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Reliance Synergy Washer/Disinfector
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements…
FDA (openFDA device enforcement)
Reported Jun 1, 2022
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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Product not approved for release for US distribution
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 3, 2021
OT1000 Series Orthopedic Surgical Tables
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Reason for recall — On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could…
FDA (openFDA device enforcement)
Reported Jan 27, 2021
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction,…
FDA (openFDA device enforcement)
Reported Jan 20, 2021
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Reason for recall — STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria…
FDA (openFDA device enforcement)
Reported Jan 13, 2021
Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 25, 2020
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Steris Corporation
Matched: Brand — Potential for cleaning solution intrusion into endoscope
FDA (openFDA device enforcement)
Reported Aug 5, 2020
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product details — A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
FDA (openFDA device enforcement)
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