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 37381–37400 of 38,428 recalls
Recalled Item: The MagNA Pure LC (version 3.0) is a sample preparation
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The COBAS 8000 data manager modular analyzer series (all versions)
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DataInnovations (Instrument Manager) (version 8.04) interfaces middleware...
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Data Station AMPLILINK software is an instrument user interface/ data
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The COBAS INTEGRA 400/400 plus system (software version 3.4) is
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DataCara GM is an information management system that provides data
The Issue: Roche Molecular Systems, Inc. has become aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral...
The Issue: Stryker has become aware that insufficient taper torsional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IR1200
The Issue: Wear of the keypad that may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: djo surgical Screw 6.5 mm
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a
The Issue: The firm voluntarily recalled the device after they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew 5.5 mm Dyonics Bonecutter
The Issue: Device labeled with an expiry period of 48
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Dyonics Electroblade Resector
The Issue: Devices labeled with an expiry period of 48
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Reliance 130 and 130L Cart Washer/Disinfector is a high
The Issue: To ensure that users are properly operating the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware that during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Dynamics Version 9.5
The Issue: If multiple uncompressed images/clips are sent to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026
The Issue: Zimmer investigation following a complaint found one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTOMIX High Speed Compounder System
The Issue: After fluid ingress into the keypad of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTOMIX 3+3 Compounder with Accusource Monitoring System
The Issue: After fluid ingress into the keypad of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTOMIX Plus High Speed Compounder System
The Issue: After fluid ingress into the keypad of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTOMIX 3+3 Compounder System
The Issue: After fluid ingress into the keypad of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.