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 22181–22200 of 38,428 recalls
Recalled Item: Malecot Nephrostomy Catheter System
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.
Recalled Item: EMPOWR Porous Knee System TIBIAL PUNCH
The Issue: The Locking Punch Guide was not sufficiently guiding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE
The Issue: The Locking Punch Guide was not sufficiently guiding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Porous Knee System TIBIAL PUNCH
The Issue: The Locking Punch Guide was not sufficiently guiding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Porous Knee System TIBIAL PUNCH
The Issue: The Locking Punch Guide was not sufficiently guiding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is
The Issue: polymer material degradation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable
The Issue: Product sterility potentially compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
The Issue: Packaging design is insufficient to prevent potential sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: digital x-ray detector ProGrade R1 - solid state X ray
The Issue: It the WiFi connection between the SkyPlate detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synvisc-One ¿ (hylan G-F 20)
The Issue: Contamination with Methylbacterium thiocyanatum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This
The Issue: A software issue causes PET reconstructions to fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew Mini-Fragment Plating System
The Issue: Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew Mini-Fragment Plating System
The Issue: Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The
The Issue: for the display processor to experience an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Widefield OCT software feature for the Spectralis HRA+OCT and variants
The Issue: FDA notified Heidelberg Engineering that a 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear...
The Issue: Due to a system controller software anomaly, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.