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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 1001–1020 of 3680 recalls

GI4000 Electrosurgical Unit (Steris) – Component Orientation Error (2022)

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 could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

Moderate

FDAOct 17, 2022Nationwide• Steris Corporation

Basin Set (American Contract) – Labeling Mismatch (2022)

Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.

Low

FDAOct 12, 2022Nationwide• American Contract Systems, Inc.

BD Nexiva IV Catheter (Becton Dickinson) – Shield Separation Risk (2022)

During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).

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Moderate

FDAOct 12, 2022FL, GA, IL +10 more• Becton Dickinson Infusion Therapy Systems Inc.

PAJUNK Epidural Tray (Pajunk) – Medication Labeling Error (2022)

The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.

Moderate

FDAOct 10, 2022Nationwide• Pajunk Medical Systems, L.P.

Utilimaster Walk-In Van (Utilimaster) – Transmission Cable Issue (2022)

Fire/Burn Risk

Shyft Group is recalling certain 2022 Utilimaster Walk-In vans. The transmission shifter cable may contact the exhaust manifold, causing the outer coating to melt and damaging the cable.

High

NHTSAOct 7, 2022Nationwide• UTILIMASTER

Canon Aplio Ultrasound (Canon) – Stress Echo Termination Problem (2022)

After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.

Moderate

FDASep 29, 2022AR, CA, CO +20 more• Canon Medical System, USA, INC.

Residential Elevators (Custom Elevator) – Child Entrapment Risk (2022)

This recall involves select Custom Elevator residential elevators with either hydraulic drives (HYD) or winding drum drives (WD). The Custom Elevator brand name is located on the controllers and hydraulic power unit. The elevators are used in consumers' homes.

High

CPSCSep 29, 2022Nationwide• Custom Elevator, of Plumsteadville, Pennsylvania

Western Star 4700 (Western Star) – Tie Rod Assembly Issue (2022)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2022-2023 Western Star 4700 and 2023 Western Star 4900, 49X, 6900, and Freightliner 114SD vehicles. The tie rod clamps may have been improperly heat-treated, causing them to crack and allowing the tie rods to separate.

High

NHTSASep 28, 2022Nationwide• WESTERN STAR

Manchester Tank Mantank (Manchester) – Valve Thread Problem (2022)

Fire/Burn Risk

Manchester Tank & Equipment Co (Manchester) is recalling certain ManTank Propane Tanks. Manchester was notified by it's valve supplier that the thread depth is less than spec, which could result in a propane leak.

High

NHTSASep 27, 2022Nationwide• MANCHESTER TANK

49X (Western Star) – Steering Shaft Bolt Issue (2022)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2022-2023 Western Star 49X and 47X vehicles. The u-joint pinch bolt on the steering shaft may detach, which can cause a loss of steering control.

High

NHTSASep 12, 2022Nationwide• WESTERN STAR

Cobas 5800 Instrument (Roche) – False Test Results (2022)

Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.

High

FDASep 8, 2022IN• Roche Molecular Systems, Inc.

K360 Scalpel Handle (Steris) – Separation Risk (2022)

Choking Hazard

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 hazard.

High

FDASep 2, 2022IL, MA, NC +2 more• Steris Corporation

Rover Mobile X-Ray System (Micro-X) – DAP Meter Calibration Error (2022)

Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

High

FDAAug 31, 2022Nationwide• Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia

Utilimaster Truck Body (Utilimaster) – Frame Weld Defect (2022)

Shyft Group (Shyft Group) is recalling certain 2018-2019 Utilimaster Work Trucks. The welds may be missing or cracked on certain areas of the truck's body mount frame.

High

NHTSAAug 31, 2022Nationwide• UTILIMASTER

Pinnacle3 Radiation Planning System (Philips) – Dose Export Error (2022)

When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.

High

FDAAug 30, 2022CA, FL, GA +18 more• Philips Medical Systems (Cleveland) Inc

Western Star 49X (Western Star) – Hood Bezel Detachment (2022)

Daimler Truck North America, LLC (DTNA) is recalling certain 2020-2023 47X and 49X vehicles. The hood bezel covers may detach.

Moderate

NHTSAAug 29, 2022Nationwide• WESTERN STAR

ARveo 8 Surgical Microscope (Leica) – Component Performance Issue (2022)

During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

Moderate

FDAAug 26, 2022Nationwide• Leica Microsystems, Inc.

Tibial Bearing MK4 (Howmedica) – Component Compatibility Issue (2022)

A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

Moderate

FDAAug 24, 2022IN, NY• Howmedica Osteonics Corp.

PTS Cholesterol Strips (PTS Diagnostics) – Instructions Error (2022)

Incorrect instructions for use were packaged into the final product.

Moderate

FDAAug 16, 2022Nationwide• Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

COVID Test Kit (American Contract Systems) – Incorrect Labeling (2022)

Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

Moderate

FDAAug 12, 2022IN, PA• American Contract Systems, Inc.