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 10561–10580 of 38,428 recalls
Recalled Item: BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta Stopcock with OFF Directed Tap Without Extension Tube
The Issue: May have the potential for leakage at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOLISTA StandOP Surgical Light
The Issue: Paint particles may detach and fall in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK" plus: Clostridium perfringens
The Issue: Labeling error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Three-Lumen CVC
The Issue: Gravity flow rates on the affected product lidstock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Battery
The Issue: Batteries for the HVAD system have a weld
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733...
The Issue: The loading cartridges included with these devices may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tornado Embolization Microcoil
The Issue: The loading cartridges included with these devices may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hilal Embolization Microcoil
The Issue: The loading cartridges included with these devices may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert
The Issue: A right, size 8, knee tibial insert package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optiflux 200NRe Dialyzer Finished Assy.
The Issue: Dialyzers were distributed after being exposed to cold
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
The Issue: One manufacturing lot is missing the plasma-spray coating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System: Alphenix 4D CT in combination with CAS-930A (C arm
The Issue: CT operation may be restricted by an interlock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: illumina Model NextSeq 550 Dx
The Issue: cybersecurity vulnerability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: illumina Model: MiSeq Dx illumina Model:
The Issue: cybersecurity vulnerability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STORZ KARL STORZ-ENDOSKOPE CMOS Video Cysto-Urethroscope
The Issue: The endoscope may experience a loss of image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS -
The Issue: for the tip of the electrode to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard GS0098C - RESUSABLE RT BRONCH
The Issue: Convenience kit contained Medline Endoscopy Bedside Cleaning products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
The Issue: Software anomaly was identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.