Health & Personal Care
HIGH
FDA DEVICE
Intuitive Surgical Recalls da Vinci 5 Console Motor Connector Due to High Hazard
Intuitive Surgical
Surgical system
These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
Immediate attention
High Risk Recalls
4,262 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.
- High-risk recalls
- 4,262
- Action level
- Stop use
What to do if you own a recalled product
- Stop using the product immediately
- Keep the product away from children
- Follow the remedy instructions provided
- Contact the manufacturer for a refund or replacement
Health & Personal Care
HIGH
FDA DEVICE
Omnia Medical TiBrid Stand Alone Fusion Device Recalled for Field Instrument Failure
Failure of fusion system instruments in the field.
Omnia Medical
Failure of
Health & Personal Care
HIGH
FDA DEVICE
Omnia Medical TiBrid Fusion Device and Angled Screwdrivers Recalled for Field Instrument Failure (Z-
Failure of fusion system instruments in the field.
Omnia Medical
Failure of
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Electrosurgical Knife Over Burning Risk
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus Corporation of the Americas
A deterioration
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Electrosurgical Knife Over Burn Hazard
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus Corporation of the Americas
A deterioration
HIGH
FDA DEVICE
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
Health & Personal Care
HIGH
FDA DEVICE
NOXBOX LTD Recalls NOxBOXi Nitric Oxide Delivery System in US for Pump Failure
Replacement of the internal Sample Pump due to high failure rates.
NOXBOX
Replacement of
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Heart Rate Monitor Cap Recalled for Sizing Error
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Medical Recalls Newborn Heart Rate Monitor Component Due to Labeling Error
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Foundation Medicine FoundationOne Liquid CDx Recall 2022 Reminds Clinicians to Check CDx Pages (18 U
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Foundation Medicine
Reports were