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 20901–20920 of 38,428 recalls
Recalled Item: GUIDE WIRE w/ BALL TIP 2.0MMX98CM
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRILL PT GUIDE WIRE 2MM X 60CM
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEAD TIP GD WIRE 3.0MM X 60CM
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRILL PT GUIDE WIRE 3.2MMX98CM
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALL TIP GUIDE WIRE 3.2MMX98CM
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALL TIP GUIDE WIRE 2.0MMX60CM
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.2MM X 510MM COCR THD TIP
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G-PIN 2.8BL 3.2PL 60CM 2PK
The Issue: The firm is recalling various trauma guide wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAREstream ProNox Nitrous Oxide Delivery System labeled as the following:
The Issue: Two analgesic gas delivery system oxygen/nitrous oxide mixers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MegaPower Electrosurgical Generator
The Issue: If two devices are plugged into the same
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XLTEK EMU40EX EEG Headbox
The Issue: degradation of an internal electronic component over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Jaundice Meter JM-103 The device is intended for use in hospitals
The Issue: Users have misinterpreted the display for out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Jaundice Meter JM-105 The device is intended for use in hospitals
The Issue: Users have misinterpreted the display for out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031
The Issue: In vitro diagnostic devices, used greater than 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foundation Modular Femoral Stem
The Issue: After receipt of a product complaint for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System
The Issue: Higher levels of nitrous oxide delivered than specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AdvanDx QuickFISH Slides
The Issue: diminished performance prior to its established expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safety Sideport Knife 1.0mm 45¿
The Issue: Blades are loose in handles and may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cryovalve(R) SG Pulmonary Human Heart Valve
The Issue: Devices, which met FDA and AATB eligibility criteria,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cryopatch SG Pulmonary Human Cardiac Branch
The Issue: Devices, which met FDA and AATB eligibility criteria,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.