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Steris Corporation

Steris Corporation Recalls

All product recalls associated with Steris Corporation.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 881–900 of 3680 recalls

Reliance Vision Washer/Disinfector (Steris) - Electrical Component Risk (2023)

Fire/Burn Risk

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 overheat, eventually resulting in smoke and/or fire.

High

FDAApr 10, 2023Nationwide• Steris Corporation

Over-Head Ceiling Tube Support (Shimadzu) - Bolt Fastening Issue (2023)

Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.

High

FDAApr 10, 2023Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Cytrellis Ellacor Micro-Coring System (Cytrellis) – Core Pattern Risk (2023)

1...43 444546 47...184

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Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring.

Moderate

FDAApr 7, 2023Nationwide• Cytrellis Biosystems, Inc.

Draeger Infinity M300 (Draeger) – Waveform Peak Dropping (2023)

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

High

FDAApr 5, 2023Nationwide• Draeger Medical Systems, Inc.

Draeger Infinity CentralStation (Draeger) – Waveform Peak Dropping (2023)

High

FDAApr 5, 2023Nationwide• Draeger Medical Systems, Inc.

Chicken Slider (White Castle) – Undeclared soy (2023)

Undeclared Allergen

Product packaged in incorrect labeling resulting in undeclared soy lecithin allergen

Class IIModerate

FDAApr 4, 2023FL, GA, IL +4 more• White Castle System

Binx io CT/NG Assay (Binx Health) – Performance Detection Issue (2023)

May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results

Low

FDAMar 29, 2023IN, PA• Binx Health, Inc. 245 1st St Ste 18 Riverview II Cambridge MA 02142-1292

Soft Hands Alcohol Antiseptic 80% (Jarman's) – Methanol Contamination (2023)

Chemical Contamination: FDA testing found Presence of methanol

Class IHigh

FDAMar 27, 2023Nationwide• Jarman's Midwest Cleaning Systems, Inc.

Alcohol Antiseptic 80% (Jarman's) – Methanol Contamination (2023)

Chemical Contamination: FDA testing found Presence of methanol

Class IHigh

FDAMar 27, 2023Nationwide• Jarman's Midwest Cleaning Systems, Inc.

Isopropyl Alcohol Antiseptic 75% (Jarman's) – Methanol Contamination (2023)

CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

Class IIModerate

FDAMar 27, 2023Nationwide• Jarman's Midwest Cleaning Systems, Inc.

Commercial Natural Gas Boilers (Burnham) – Burn Risk (2023)

Fire/Burn Risk

This recall involves the Burnham Commercial Series 8 EP Natural Gas Boiler and the Series 16H equipped with CSD-1. Both boilers are for commercial use and use natural gas as a fuel source. The recalled units have the Q3452B2100/B pilot with the 90-degree mounting bracket. The brand names "Burnham Commercial" for the Series 8 and "Crown Boiler" for the Series 16H are stamped in metal on the front cover. The model and serial number can be found on the boiler rating plate located on the vestibule panel located behind the front jacket panel of the boiler. These boilers are mostly found in industrial or commercial buildings.

High

CPSCMar 23, 2023Nationwide• Burnham Commercial, of Lancaster, Pennsylvania

HyVee Chili Macaroni Skillet Meal (Gilster-Mary Lee) – Undeclared Milk (2023)

Undeclared Milk

Undeclared milk

Class IHigh

FDAMar 23, 2023IL, IN, IA +6 more• Gilster-Mary Lee Corp.

Aesculap Caiman Articulating Device (Aesculap) – spring detachment risk (2023)

Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.

Moderate

FDAMar 21, 2023Nationwide• Aesculap Implant Systems LLC

Philips Azurion System (Philips) – X-ray functionality loss (2023)

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

Moderate

FDAMar 21, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

COBRA-OS Sheath Introducer (Merit Medical) – incorrect needle size (2023)

Custom sheath Introducer contains incorrect needle size

Low

FDAMar 21, 2023MN• Merit Medical Systems, Inc.

Steris Light Handle Cover (Steris) – detachment risk (2023)

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

Moderate

FDAMar 17, 2023Nationwide• Steris Corporation

Quantum Perfusion Systems (Spectrum Medical) – bobbin lock fault (2023)

The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

Moderate

FDAMar 13, 2023Nationwide• Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom

MAKO RESTORIS MCK Baseplate Trial (Stryker) – Incorrect Size Marking (2023)

Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

Moderate

FDAMar 10, 2023Nationwide• Howmedica Osteonics Corp.

Stryker MAKO Baseplate Trial (Howmedica) – incorrect size marking (2023)

Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

Moderate

FDAMar 10, 2023Nationwide• Howmedica Osteonics Corp.

CAPIOX RX15 Oxygenator (Terumo) – Thermistor Bonding (2023)

Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

High

FDAMar 1, 2023Nationwide• Terumo Cardiovascular Systems Corporation