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 20861–20880 of 38,428 recalls
Recalled Item: LFIT Anatomic CoCr Femoral Heads
The Issue: The recalling firm has received a higher than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LFIT Anatomic CoCr Femoral Heads
The Issue: The recalling firm has received a higher than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LFIT Anatomic CoCr Femoral Heads
The Issue: The recalling firm has received a higher than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2)
The Issue: The recalling firm has confirmed that Free Kappa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1)
The Issue: The recalling firm has confirmed that Free Kappa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3)
The Issue: The recalling firm has confirmed that Free Kappa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Digital PET/CT System
The Issue: The block used to connect the patient pallet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXCOR Pediatric Ventricular Assist Device Blood Pumps
The Issue: There is a potential for a disruption in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO
The Issue: GUANGZHOU WONDFO BIOTECH discovered on the TCube One
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO
The Issue: GUANGZHOU WONDFO BIOTECH discovered on the TCube One
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO
The Issue: GUANGZHOU WONDFO BIOTECH discovered on the TCube One
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AmniSure ROM Test under the following labels: 1) Catalog Number
The Issue: for control line not appearing on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus Neurology ErgoJust Carts labeled as the following: ICU Cart
The Issue: Natus Neuro has discovered a possible manufacturing defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNI Hip System
The Issue: The Internal packaging, the pouch and patient labels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REPLANT 5.0mmD ABUTMENT
The Issue: Due to out of specification, the clinician would
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Modular Primary Tibial Tray Implants
The Issue: One lot of 75mm tibial tray is potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The da Vinci Xi Surgical System (IS4000) Model Name: IS4000
The Issue: An Endoscope Controller has been improperly calibrated during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peripherally Inserted Midline Catheter Kit with Placement Wire
The Issue: Product pouch label may not easily identify the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VPS TipTracker Stylet Accessory
The Issue: Product pouch label may not easily identify the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VPS Rhythm ECG Accessory Pack
The Issue: Product pouch label may not easily identify the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.