Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
1,218 detailed records are currently available in this category.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential…
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the…
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the…
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to…
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that…
Some of the Calibration/Output Certificates had the outputs reversed.
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This…
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the…
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Due to incorrect shelf-life expiration date.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the…
Due to customer complaint regarding incorrect display box labeling.
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
