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 23821–23840 of 38,428 recalls
Recalled Item: ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable
The Issue: There is a possibility that the finished good
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter...
The Issue: There is a possibility that the finished good
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally
The Issue: There is a possibility that the finished good
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE SIRUS Surgical Gown
The Issue: The sleeve seam of the breathable material was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissu-Trans Filtron 500
The Issue: Seal integrity of the Tissu-Trans product sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissu-Trans Filtron 250
The Issue: Seal integrity of the Tissu-Trans product sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissu-Trans MEGA 1500
The Issue: Seal integrity of the Tissu-Trans product sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissu-Trans SFILL 360
The Issue: Seal integrity of the Tissu-Trans product sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissu-Trans Filtron 100
The Issue: Seal integrity of the Tissu-Trans product sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VASER Amplifier
The Issue: inaccurate calibration by service depot repair, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VASER PRO Amplifier
The Issue: inaccurate calibration by service depot repair, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissu-Trans Filtron 2000
The Issue: Seal integrity of the Tissu-Trans product sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tissu-Trans Filtron 1000
The Issue: Seal integrity of the Tissu-Trans product sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above
The Issue: Label on the affected devices incorrectly identifies the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below
The Issue: Label on the affected devices incorrectly identifies the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi Surgical System Product Usage: The da Vinci
The Issue: da Vinci Xi(R) Surgical System Patient Side Carts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Precision Glide Needle 18G x 1 RB
The Issue: Hub damage resulting in breakage and/or leakage during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoftLab Software Laboratory information system to be used in a
The Issue: Display of lab results based on incorrect LOINC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection
The Issue: PerkinElmer 226 Sample Collection Devices Lot Number 317114
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3DKNEE(TM) SYSTEM e+
The Issue: Mis-pack. A size 6 Left 3DKnee Tibial Insert
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.