HIGH
FDA FOOD
Spice Powder, 4 oz, Plastic Bag
Lead level was higher than NYSAGM Standard.
Summit Import
Lead level
All Product Recalls
Browse through 3,598 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.
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
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
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
Food & Beverages
HIGH
FDA FOOD
Mothers' Milk Bank of Alabama Recalls Donor Human Milk Due to Contamination Risk
Mothers' Milk Bank of Alabama recalled 25 bottles of pasteurized donor human milk on August 18, 2024. The recall follows concerns about potential physical contaminants. Consumers in Alabama should not consume this product and should seek refunds or replacements.
Mothers' Milk Bank of Alabama
Potential physical
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
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
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
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
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
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Medical Recalls Newborn Heart Rate Monitor Component Due to Labeling Error
Surepulse Medical recalled a component of its newborn heart rate monitor on January 20, 2023. The recall affects the VS Cap Medium REF: SP-161-A1 due to incorrect sizing information on the label. This issue poses a high risk to patients and healthcare providers using the device.
SUREPULSE MEDICAL
Retroactively reported;
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;
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;
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;
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;
Health & Personal Care
HIGH
FDA DEVICE
Foundation Medicine FoundationOne CDx Recalled for Missing Companion Diagnostic Claims Page
Foundation Medicine recalled 59 units of FoundationOne CDx (F1CDx), RAL-0003 version 31.0 after reports indicated the companion diagnostic Claims Page was omitted. This oversight could impact patient care and healthcare provider decisions concerning diagnosis and treatment. Users should stop using the device and contact Foundation Medicine or their healthcare provider for further instructions.
Foundation Medicine
Reports were
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
Health & Personal Care
HIGH
FDA DEVICE
Philips Ultrasound Systems Recalled Over Automatic Reboot Risk
Philips recalled 1,721 EPIQ Ultrasound Systems on July 14, 2022. The ultrasound may unexpectedly reboot, damaging the transducer. Healthcare providers must stop using the device immediately.
Philips Ultrasound
Retroactive: Ultrasound
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