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 30141–30160 of 38,428 recalls
Recalled Item: enGen Laboratory Automation System (enGen System)
The Issue: Recapper Caps may fall off of, or be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R3(TM) 28 MM I.D.
The Issue: The R3 Constrained outer liner locking groove diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R3(TM) 22 MM I.D.
The Issue: The R3 Constrained outer liner locking groove diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Workflow SLR
The Issue: A potential exists for order transactions from interfaced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Signal Reagent
The Issue: The Immunodiagnostic Products Signal Reagent, Lot 3082 as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D2-40 (Lymphatic Marker)
The Issue: Firm discovered that incorrect Instructions for Use were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Avant Garde
The Issue: safety risk of collision of the LINAC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha
The Issue: under certain circumstances the Cios Alpha system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Passive Planar Blunt Probe Part Number 960-556
The Issue: Passive Planar Blunt Probe (Lot# 150223) was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device
The Issue: device damage on the strain relief near
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
The Issue: The Astral device allows clinicians to disable all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75....
The Issue: The product failed to meet the internal established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: The heart rate could be calculated from pacer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine Wave Access Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Navigation System II-Cart
The Issue: Stryker initiated a device recall of the Navigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Low Volume Extension Set
The Issue: Smiths Medical has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Blood Agar (TSA w/sheep blood) plate packaged
The Issue: Listeria Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e
The Issue: It was found by R&D in April, 2014
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and
The Issue: Baxter healthcare is recalling specific product codes of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno
The Issue: The firm discovered an improperly installed set screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.