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 36781–36800 of 38,428 recalls
Recalled Item: Eterna Giovinezza System
The Issue: Quanta System S.p.A, Italy, is notifying U.S. consignees
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser
The Issue: Quanta System S.p.A, Italy, is notifying U.S. consignees
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and
The Issue: Quanta System S.p.A, Italy, is notifying U.S. consignees
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Analyzing system consists of a small and portable analyzer and
The Issue: Incorrect version of Quick Reference Guide (QRG) was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated
The Issue: for self activation while the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare Height Adjustable (walking) Canes
The Issue: Following their receipt of several customer complaints, Invacare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix PMIC-108 Panels
The Issue: An antibiotic susceptibility test kit may produce false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous
The Issue: It was reported that the surgeon noticed that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDRAD Hand Controller Sheath
The Issue: The seal between the white polyethylene and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech NOVATION CROWN CUP
The Issue: Recall of Novation Crown Cup Connection GXL Neutral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER
The Issue: Recall of Novation Crown Cup Connection GXL Neutral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra
The Issue: One lot of Lifestyles Pleasure Collection Lubricated Condoms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparoscope
The Issue: Applied Medical is conducting a voluntary recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian brand ARIA Radiation Oncology
The Issue: Varian Medical Systems has identified an anomaly with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAYFIELD Composite Series Base Unit
The Issue: An investigation of an adverse trend of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Access hLH assay is a paramagnetic particle
The Issue: Beckman Coulter Inc. (BEC) has demonstrated that real
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAYFIELD Composite Series Skull Clamps
The Issue: An investigation of an adverse trend of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arobella Medical 6mm Qurette used with the Arobella Medical AR1000
The Issue: This recall has been initiated because the Arobella
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniGuide BP-ROBOTIC ( BeamPath Robotic)
The Issue: Failure of glue joint, allowed a portion of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTec V-Sign Membrane Changer Insert (VS-MCI)
The Issue: A manufacturing defect was observed for the membrane
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.