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 22161–22180 of 38,428 recalls
Recalled Item: BrightView X
The Issue: During collimator exchange, the alignment of the collimator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precedence 16 Model # 882350 Product Usage: Precedence (cleared as
The Issue: During collimator exchange, the alignment of the collimator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DermaPro Waterproof Silicone Tape
The Issue: The recalling firm received a customer complaint stating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase
The Issue: Calibration failure - confirmed a positive bias with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle
The Issue: Falsely elevated results may be obtained when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dynavox T15 Speech Generating Device ( including Batteries)
The Issue: The battery is integral to the device. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dynavox T10 Speech Generating Device ( including Batteries)
The Issue: The battery is integral to the device. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008 K2 Hemodialysis Machine with software version 5.40
The Issue: When the recirculation ultrafiltration (UF) Goal is set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers
The Issue: Merit Medical Systems, Inc. is voluntarily conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vado Steerable Sheath 8.8F
The Issue: Torn sheath liner material was detected at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vado Bi-Directional Steerable Sheath 8.8F
The Issue: Torn sheath liner material was detected at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11-VI Incorporated Laser diode component Non-certified laser diode component...
The Issue: Affected diodes incorporated in the laser sights emitted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy)
The Issue: Foley Catheter with Incorrect Retainer Cap Print
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with...
The Issue: The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signia" Power Handle (SIGPHANDLE
The Issue: Product reportedly shutting down during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Taylor Spatial Frame Website software
The Issue: In rare circumstances, when surgeons use the software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG
The Issue: A complaint was received for Item 42-5320-067-02, lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Access Set
The Issue: Certain Malecot Nephrostomy Catheters are breaking at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Re-Entry" Malecot Nephrostomy Catheter Set
The Issue: Certain Malecot Nephrostomy Catheters are breaking at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malecot Nephrostomy Catheter Set
The Issue: Certain Malecot Nephrostomy Catheters are breaking at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.