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 38221–38240 of 38,428 recalls
Recalled Item: Video Naso pharyngo Laryngoscopes
The Issue: This field action serves to retrospectively document the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SteriGear Urinary Drain Bag with Fig Leaf Cover
The Issue: SteriGear notifed customers of circumstances in which The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I-STAT EG7+ Cartridge Abbott Point of Care
The Issue: i-Stat EG7 cartridges may generate falsely depressed PCO2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ULTRA Fabric Reinforced Surgical Gown
The Issue: The impacted product was not intended for commercial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M3150 Information Center Local Database
The Issue: for early component failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part #
The Issue: The recall was initiated because Alphatec Spine confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BCS(R) Behring Coagulation System
The Issue: Firm has confirmed that if the Cleaner SCS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
The Issue: The main harness connector was manufactured without the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level
The Issue: Incorrect control range in product labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors...
The Issue: Inaccurate readings. Software contains unused (turned off) accuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Solid State X-ray Imager (Flat Panel/Digital Imager)
The Issue: Screws holding the 55REF circuit board are loosening
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic 0-arm Imaging System with Software Version 3.1.1
The Issue: Software Version 3.1.1 does not meet navigational accuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS
The Issue: Surgical technique instructions for the Versys and Slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.