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 9081–9100 of 38,428 recalls
Recalled Item: Invisalign Express 10 Invisalign System Comprehensive
The Issue: 3D orthodontic planning software has a defect that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agfa HealthCare Enterprise Imaging XERO Viewer
The Issue: There is a software defect that can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHIP KIT
The Issue: A software update (v1.1.5) has been developed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Denticator PICK-A-DENT
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncentra Brachy radiation therapy planning system software.
The Issue: A reconstruction error may occur when using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta/Seqenita LT Clinician Programmer Application
The Issue: Software anomalies, CP App messages: "Too Many Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta/Seqenita LT Clinician Programmer Application
The Issue: Software anomalies, CP App messages: "Too Many Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta/Seqenita LT Clinician Programmer Application
The Issue: Software anomalies, CP App messages: "Too Many Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta/Seqenita LT Clinician Programmer Application
The Issue: Software anomalies, CP App messages: "Too Many Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta/Seqenita LT Clinician Programmer Application
The Issue: Software anomalies, CP App messages: "Too Many Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31...
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgidac Uncoated Braided Polyester suture Product Description D-1764K...
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgipro II Monofilament Polypropylene Sutures Product Description Model...
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41...
The Issue: Sterile Barrier Breach of Breather Pouch may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.