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 35561–35580 of 38,428 recalls
Recalled Item: Medtronic INDURA 1P Intrathecal Catheter
The Issue: The Sutureless Connector (SC) Intrathecal Catheter connector has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMC Saddle Product Usage: The Ascension CMC is intended to
The Issue: As a result of a quality review, labelling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed EL Programmable pumps
The Issue: Medtronic Neuromodulation is providing Healthcare Providers with safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and
The Issue: The firm is initiating a Field Safety Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi Vector Distractor Pin Holding Clamp
The Issue: Synthes is initiating a voluntary Medical Device removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 27023WU Balloon Catheter
The Issue: Karl Storz Endoscopy-America has initiated the recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX Instrument
The Issue: Electrical power module installed on some in vitro
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis a Johnson & Johnson Company
The Issue: Cordis Corporation, Inc and Greatbatch Medical are recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large
The Issue: Stryker has received reports from customers indicating post-operative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Articulated Driver A nonpowered hand-held device intended for medical
The Issue: When torque is applied to the Articulated Driver
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum
The Issue: When the bed is put into the chair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEO-MED ORTHO TOTAL JOINT TRACECART(R)
The Issue: DeRoyal recalled kits that contained Stryker togas which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******QTY 1***APEX Arthroscopy Tubing Set. Intended for use for
The Issue: Conmed Linvatec received complaints that their products C7120
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******APEX Arthroscopy Tubing Set. Intended for use for joint
The Issue: Conmed Linvatec received complaints that their products C7120
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle¿ Destination¿ Peripheral Guiding Sheath
The Issue: Medical devices were incorrectly labeled with extended expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Glidesheath (tm)
The Issue: Medical devices were incorrectly labeled with extended expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns " TCM II Temperature Control Module The Sarns" TCM
The Issue: Internal testing found certain Sarns" TCM II systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI
The Issue: A plate was inadvertently released to a sales
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R3 (TM) XLPE ACETABULAR LINER UHMWPE
The Issue: One batch of 60 mm 20o R3 XLPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R3 (TM) XLPE ACETABULAR LINER UHMWPE
The Issue: One batch of 60 mm 20o R3 XLPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.