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 27161–27180 of 38,428 recalls
Recalled Item: M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Periarticular plating system
The Issue: A small hole may be present in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic RestoreSensor
The Issue: Loss of therapy during recharging of device. Reportedly,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument
The Issue: A patient specific case of Signature Personalized Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DX-D600 - DXD Imaging Package
The Issue: One of the dent markers from the DX-D600
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CytoVision Image Analysis and Capture System
The Issue: Systems have an improperly activated Windows 7 OS,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for
The Issue: Exhibits a greater than 10% change in results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAAR AQ Cartridge-FP
The Issue: The STAAR AQ Cartridge-FP may malfunction and may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile
The Issue: Product incorrectly packaged. The labels on the outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 8.0 mm Flexible Shaft Reamer
The Issue: Devices did not pass the biological safety evaluation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile
The Issue: Labeling errors. The outer packge label expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile
The Issue: Labeling errors. The outer packge label expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile
The Issue: Labeling errors. The outer packge label expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 CT Model 728231
The Issue: Software issues found in software versions v4.1.3/4.1.4/4.1.5 in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT SP Model No. 728311
The Issue: Software issues found in v4.1 .3/4.1.5 in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Model No. 728321
The Issue: Software issues in software versions v4.1.3/4.1.4/4.1.5 in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.