Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 31741–31760 of 38,428 recalls
Recalled Item: I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM
The Issue: Use of excessive force when impacting may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheridan/CF Cuffed Tracheal Tube
The Issue: Product Labeling; Units from the affected lot indicates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlignRT is a video-based three-dimensional (3D) surface imaging system which
The Issue: use error when the external Gate Controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotranslucent Electrode
The Issue: Heart Sync Multi-function defibrillation electrodes will not connect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594
The Issue: A design deficiency was discovered whereby the Drill/Awl
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotransparent Electrode
The Issue: Heart Sync Multi-function defibrillation electrodes will not connect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT/CHILD Radiotranslucent Electrode
The Issue: Heart Sync Multi-function defibrillation electrodes will not connect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotranslucent Electrode
The Issue: Heart Sync Multi-function defibrillation electrodes will not connect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT/CHILD Radiotransparent Electrode
The Issue: Heart Sync Multi-function defibrillation electrodes will not connect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Miethke Shunt System
The Issue: Aesculap Inc. (AIC (USA)) initiated a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza
The Issue: Printouts may be printed in incorrect anatomical size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps Sterile RX
The Issue: The product is sold and labeled as EO
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pediatric
The Issue: Some of the intermediate boxes within lot 140417-3,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Optional Laser Centering Device X-ray generator.
The Issue: GE has identified a potential failure to comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer
The Issue: The firm is informing customers of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate
The Issue: Incorrect lumi firmware version installed (E.027 instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized
The Issue: Complaints have indicated that the ATTUNE INTUITION Impaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite 200 The Tecan Infinite 200 is a multifunctional microplate
The Issue: Incorrect lumi firmware version installed (E.027 instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors
The Issue: ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSA Medical truFreeze System
The Issue: An increase in complaint trending for a loss
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.