cpsc regulated Recalls

2,142 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Lithotomy Packs Over Sterility Concerns

Medline Industries recalled 808 lithotomy packs on January 7, 2026, due to calibration issues in sterilization equipment. These problems may compromise the sterility assurance level of the products. Healthcare providers and patients must stop using these devices immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Convenience Kits Over Sterility Issues

Medline Industries, LP recalled 684 medical convenience kits on January 7, 2026. The recall affects the LVAD Driveline Tray and the KIT Surg Onc Insert Cent. Venou due to calibration issues impacting sterility. Health providers and patients should stop using these products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Convenience Kits Recalled Due to Sterility Issues

Medline Industries recalled 30,958 convenience kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Healthcare providers and patients must stop using these products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Convenience Kits Over Sterility Concerns

Medline Industries recalled 9,720 convenience kits on January 7, 2026, due to sterilization calibration issues. The affected products may not meet sterility assurance levels. Patients and healthcare providers should stop using these kits immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Convenience Kits Recalled Due to Sterility Concerns

Medline Industries recalled 7,725 surgical kits on January 7, 2026, due to potential sterility issues. Calibration problems with sterilization equipment may compromise the sterility assurance level. Healthcare providers and patients should stop using these kits immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls IQon Spectral CT Over Potential Rotor Hazards

Philips North America recalled 52 units of the IQon Spectral CT on January 7, 2026, due to fasteners that may not be torqued to specification. This defect may lead to unsecured rotor parts during operation. No injuries have been reported, but the potential for parts to be expelled during gantry rotation poses a safety risk.

Philips North America
As part
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Convenience Kits Over Sterility Concerns

Medline Industries recalled 4,757 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple models, raising concerns about sterility assurance levels. Patients and healthcare providers should stop using these products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Surgical Kits Over Sterility Concerns

Medline Industries recalled 12,418 surgical kits on January 7, 2026, after identifying calibration issues in sterilization equipment. The defects could compromise sterility assurance levels of the devices. Healthcare providers and patients must stop using the affected products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 1,072 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall addresses devices that did not undergo proper thermoforming, risking performance failure. Healthcare providers and patients should stop using the devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Philips North America Recalls CT Scanner Over Rotor Fastener Issue

Philips North America recalled 47 CT scanners on January 7, 2026, due to improperly torqued rotor fasteners. This issue could lead to unsecured rotor parts, posing a high risk during operation. Patients and healthcare providers must stop using the device immediately.

Philips North America
As part
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Burn Care Kits Due to Sterility Issues

Medline Industries recalled 291 units of burn care kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Users should stop using the affected products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to High Hazard Risk

Olympus Corporation recalled 887 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform and lose performance if not properly thermoformed. The recall affects both US and international markets.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Potential Performance Issues

Olympus Corporation of the Americas recalled 1,980 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo thermoforming, risking deformation and loss of performance. Healthcare providers must stop using these devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to High Risk of Deformation

Olympus Corporation of the Americas recalled 125 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers must stop using these devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 10,257 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall follows reports that some devices did not undergo thermoforming, risking deformation and loss of performance during medical procedures. This recall affects both domestic and international distribution, including 274 units in the U.S.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Medline Surgical Kits Recalled Over Sterility Concerns

Medline Industries recalled 9,051 surgical kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple model numbers and poses a high hazard risk. Patients and healthcare providers should stop using these products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation of the Americas recalled 7,689 Disposable Triple Lumen Sphincterotomes on January 7, 2026. The devices may deform due to inadequate thermoforming, risking performance failure during medical procedures. Healthcare providers must stop using these devices immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Risk of Deformation

Olympus Corporation of the Americas recalled 1,490 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform due to improper thermoforming, risking performance failure. Healthcare providers should immediately stop using these devices and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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