cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

MEDITECH Expanse Lab Calculator Module Recalled for Input Error Risk in 2025

MEDITECH released an active recall for the Expanse Laboratory calculator/data processing module. The recall covers 148 units distributed worldwide, including the US, UK, Canada, Ireland and the British Virgin Islands. The hazard concerns simultaneous multi-key inputs potentially removing data from the first field in screens or questionnaires.

Medical Information Technology
Entering multiple
Read more
Vehicles & Parts
HIGH
NHTSA

Subaru Forester 2025 Wheels Recall Over Lug Seat Issue

Subaru of America, Inc. is recalling certain 2025 Forester vehicles equipped with 18-inch aluminum alloy wheels. The lug seat surface may be incorrectly specified, which can cause the wheel to detach and reduce vehicle stability. Owner notification letters were mailed February 28, 2025, and dealers will inspect and replace the wheels as necessary at no charge.

Subaru
A loss
Read more
Health & Personal Care
HIGH
FDA DEVICE

CorNeat Vision EverPatch 1036295 Recall for Labeling Update in 2024

CorNeat Vision recalled EverPatch surgical matrix (REF 1036295) in a worldwide distribution that includes 50 states and several countries. The recall addresses retroactive labeling corrections to include prevention and management of would dehiscence. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.

CorNeat Vision
Retroactive; Due
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus Cystoscope Outer Sheath Recalled Over Laser Incompatibility

Olympus Corporation of the Americas recalled 633 units of the Cystoscope Outer Sheath, Model WA22810A on September 13, 2024. The recall occurred due to potential device damage when used with a GreenLight Laser for BPH therapy. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Product being
Read more
Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls da Vinci 5 Console Motor Connector Due to High Hazard

Intuitive Surgical recalled 144 units of the da Vinci 5 Surgeon Console Column Motor Connector on August 21, 2024. Users reported a potential ergonomic lock issue that could delay or abort surgical procedures. Healthcare providers must stop using the devices immediately and follow the recall instructions.

Intuitive Surgical
Surgical system
Read more
Health & Personal Care
HIGH
FDA DEVICE

Omnia Medical TiBrid Stand Alone Fusion Device Recalled for Field Instrument Failure

Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device SA Angled Punch Awl. The recall covers models 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5 with UDI 00843511113056 and 00843511122287/22294. The hazard is failure of fusion system instruments in the field. Consumers should stop use and follow recall instructions.

Omnia Medical
Failure of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Omnia Medical TiBrid Fusion Device and Angled Screwdrivers Recalled for Field Instrument Failure (Z-

Omnia Medical issued a recall for 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device and TiBrid SA Angled Screwdrivers after field failures were reported. The recall covers nationwide distribution in AZ, CA, NJ, NV, OK and WA. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

Omnia Medical
Failure of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Electrosurgical Knife Over Burning Risk

Olympus Corporation of the Americas recalled the Single Use Electrosurgical Knife KD-640L on February 17, 2024. The recall follows reports of overheating and potential tip breakage during surgery. Healthcare providers and patients must stop using the device immediately to avoid injuries.

Olympus Corporation of the Americas
A deterioration
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Electrosurgical Knife Over Burn Hazard

Olympus Corporation recalled 3,361 Single Use Electrosurgical Knives on February 17, 2024, due to burn risks from tip breakage. The recall affects model KD-645L, distributed nationwide. The defective knives may overheat and deteriorate during use, posing serious safety risks.

Olympus Corporation of the Americas
A deterioration
Read more
Health & Personal Care
HIGH
FDA DEVICE

NOXBOX LTD Recalls NOxBOXi Nitric Oxide Delivery System in US for Pump Failure

NOXBOX LTD recalls 1,667 NOxBOXi Nitric Oxide Delivery Systems distributed nationwide in the United States, including Tennessee. The recall centers on replacing the internal Sample Pump due to high failure rates. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions for recall remediation.

NOXBOX
Replacement of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error

Surepulse Medical recalled its VS Cap Extra Small component of the VS Newborn Heart Rate Monitor on January 20, 2023. The recall affects devices distributed in the US and several other countries due to an incorrect sizing guide. Consumers must stop using the device immediately and follow manufacturer instructions.

SUREPULSE MEDICAL
Retroactively reported;
Read more
Health & Personal Care
HIGH
FDA DEVICE

Surepulse Heart Rate Monitor Cap Recalled for Sizing Error

Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.

SUREPULSE MEDICAL
Retroactively reported;
Read more
Health & Personal Care
HIGH
FDA DEVICE

Surepulse Medical Issues Recall for Newborn Heart Rate Monitor Component

Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.

SUREPULSE MEDICAL
Retroactively reported;
Read more
Health & Personal Care
HIGH
FDA DEVICE

Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error

Surepulse Medical recalled its VS Cap Large component for the newborn heart rate monitor on January 20, 2023. The recall addresses an incorrect sizing guide that could affect patient safety. This recall impacts distribution in the US and several countries including the UK and UAE.

SUREPULSE MEDICAL
Retroactively reported;
Read more
Health & Personal Care
HIGH
FDA DEVICE

Foundation Medicine FoundationOne Liquid CDx Recall 2022 Reminds Clinicians to Check CDx Pages (18 U

Foundation Medicine issued a recall affecting 18 FoundationOne Liquid CDx tests, including 17 in the United States and 1 overseas. The defect is the absence of the companion diagnostic CDx Claims Page in reports. Amended claims pages were distributed within seven days. Stop use immediately and follow manufacturer instructions.

Foundation Medicine
Reports were
Read more
Previous
12345...103

Tag Statistics

Total Recalls
2,056

Related Tags

electrical hazardpoisoning riskchemical hazardimmediate actionreturn for refundfda regulatednhtsa regulatedworkplaceholiday productsuffocation riskinfant producttoddler product