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 37101–37120 of 38,428 recalls
Recalled Item: SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Screw
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number:
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number:
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile
The Issue: The wrong electrical connector pin was attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single...
The Issue: The Wireless Portable Detector (WPD) is not fixed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: During the investigation of four returned Z Flex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Effort
The Issue: Contact between the bur and bur guard could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mindray DPM5 Monitor
The Issue: Mindray has identified an issue with the DPM5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.