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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 1501–1520 of 3680 recalls

Vis-U-All High Temp 3.5x9 Pouch (Steris) – Ink Migration Issue (2020)

Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch

Low

FDADec 2, 2020Nationwide• Steris Corporation

uPath Software (Roche) – Measurement Tool Calculation Error (2020)

When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.

Moderate

FDANov 23, 2020MD, MI• Roche Molecular Systems, Inc.

Cobas Z 480 Analyzer (Roche) – Dirty Lens Issue (2020)

Dirty Lens May Cause Invalid or False Positive Results

Moderate

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FDA

Nov 19, 2020

Nationwide

• Roche Molecular Systems, Inc.

Medisafe Distal Duck Kit (Steris) – Bacterial Contamination (2020)

STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.

Moderate

FDANov 19, 2020Nationwide• Steris Corporation

Trinias X-Ray System (Shimadzu) – Ceiling Arm Control Issue (2020)

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

Moderate

FDANov 18, 2020Nationwide• Shimadzu Medical Systems

MH-200S X-Ray System (Shimadzu) – Ceiling Arm Control Issue (2020)

Moderate

FDANov 18, 2020Nationwide• Shimadzu Medical Systems

ENNOVATE MIS RemovalKey (Aesculap) – Instrument Fracture Risk (2020)

Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

High

FDANov 18, 2020Nationwide• Aesculap Implant Systems LLC

Bransist Safire X-Ray System (Shimadzu) – Ceiling Arm Control Issue (2020)

Moderate

FDANov 18, 2020Nationwide• Shimadzu Medical Systems

Canon PET-CT Scanner (Canon) – Scan Progression (2020)

A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.

FDANov 11, 2020Nationwide• Canon Medical System, USA, INC.

Capiox FX25 Oxygenator (Terumo) – Configuration Error (2020)

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

FDANov 11, 2020Nationwide• Terumo Cardiovascular Systems Corporation

Cardiac Cath Pack (Merit Medical) – Sterile Barrier (2020)

Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.

FDANov 10, 2020KY, MD, RI• Merit Medical Systems, Inc.

Custom Inflation Kit (Merit Medical) – Sterile Barrier (2020)

FDANov 10, 2020KY, MD, RI• Merit Medical Systems, Inc.

Embolization Kit (Merit Medical) – Sterile Barrier (2020)

FDANov 10, 2020KY, MD, RI• Merit Medical Systems, Inc.

Shimadzu Mobile X-Ray (Shimadzu) – Handle Bolts (2020)

There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.

FDANov 9, 2020Nationwide• Shimadzu Medical Systems

Canon Aquilion Prime CT (Canon) – Scan Progression (2020)

A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.

FDANov 9, 2020Nationwide• Canon Medical System, USA, INC.

Cannulated Drill Bit (Neosteo) – Corrosion Risk (2020)

Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the 4.5mm surgical motor using a AO 4.5mm male drive connexion. The countersink bit is coupled to a 1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.

FDANov 3, 2020Nationwide• NEOSTEO 2 rue Robert Schuman Reze France