Medical Device Recalls
The most recent FDA medical-device recalls affecting healthcare technology, gathered from the openFDA device enforcement database.
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different fir
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely
MOSAIQ Oncology Information System
Class IISoftware may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TY
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TY
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulat
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Class IISterile wound dressing, lacks sterility assurance
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
ALYON Surgical Lighting System
Class IIThe the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Due to 11 volt Backup Battery failures.
Due to 11 volt Backup Battery failures.
Due to 11 volt Backup Battery failures.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence o
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminat
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurr
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a produ
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a produ
Due to unsealed portions of pouches.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the inten
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the inten
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the inten
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not c
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not c
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctl
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may no
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary re
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary re
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing