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 1601–1620 of 38,428 recalls
Recalled Item: Dexcom G7 Continuous Glucose Monitoring System Product Name:
The Issue: The affected devices are the Dexcom G7 Continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX
The Issue: The potential for a failed welded nut to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlantis IO FLO Product Name: Atlantis IO FLO-S
The Issue: The defect in the thread area will not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S
The Issue: The defect in the thread area will not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190
The Issue: The potential for a failed welded nut to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX
The Issue: The potential for a failed welded nut to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software
The Issue: The potential for a failed welded nut to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOTAK RELIANCE G/SG with 4-SITE Connector
The Issue: Affected lead models may experience gradually rising LVSI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RELIANCE 4-FRONT
The Issue: Affected lead models may experience gradually rising LVSI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOTAK RELIANCE G/SG
The Issue: Affected lead models may experience gradually rising LVSI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description:...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451
The Issue: Due to required inspections not being performed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022
The Issue: Due to required inspections not being performed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001...
The Issue: Due to incorrect software configuration that potentially allows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023
The Issue: Due to required inspections not being performed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OtoLase Starter Kit
The Issue: The potential for unsterilized product within finished product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro
The Issue: for Bartels ELISA Legionella Urinary Antigen kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELSITE Product Name: CELSITE BABYPORT SET PUR 4
The Issue: The potential for minor injury such as damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Battery Operated infusion pumps. t:slim X2 G5
The Issue: Insulin pumps manufactured with speakers from Revision A
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid
The Issue: for contamination of STA-LIQUID ANTI-Xa by Stago
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.