Recalls and safety alerts from the FDA, newest first.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. — B Braun Medical Inc · Class I · Ongoing
Temperature probe devices lack FDA clearance. — Covidien LLC · Class II · Ongoing
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. — Draeger, Inc. · Class I · Ongoing
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 butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
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 an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
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 reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disenga… — Bayer Medical Care, Inc. · Class II · Ongoing
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 footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope. — Intuitive Surgical, Inc. · Class II · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
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 an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
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. — Kico Knee Innovation Company · Class II · Ongoing
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 your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable. — Stryker Corporation · Class II · Ongoing
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 the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. Th… — KAYSERBETTEN GMBH & CO. KG · Class I · Ongoing
Some of the Calibration/Output Certificates had the outputs reversed. — Daavlin Distributing Company · Class II · Ongoing
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 footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
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 could impact clinical decision-making. — GE Medical Systems China Co., Ltd. · Class II · Ongoing
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 butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
Due to incorrect shelf-life expiration date. — Advanced Bionics, LLC · Class II · Ongoing
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 butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
Due to customer complaint regarding incorrect display box labeling. — Covidien LLC · Class II · Ongoing
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 footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing