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 34341–34360 of 38,428 recalls
Recalled Item: Medtronic Delta Shunt Assembly Kit with Bioglide Small
The Issue: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Strata II Shunt Assembly Kit
The Issue: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSF-Unitized Shunt
The Issue: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
The Issue: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile X-ray System
The Issue: Shimadzu Corporation is recalling the Shimadzu Mobile X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrainLAB's VectorVision spine is intended for use as an intraoperative
The Issue: Brainlab has determined that pins of thee Instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens SOMATOM Definition
The Issue: During clinical operation, a malfunction may occur causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
The Issue: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mega Needle Driver
The Issue: Firm has become aware of the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
The Issue: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Large Needle Driver
The Issue: Firm has become aware of the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Renasys EZ PLUS
The Issue: Modification of the bacterial overflow guard (filter) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Renasys EZ
The Issue: Modification of the bacterial overflow guard (filter) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.