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 26881–26900 of 38,428 recalls
Recalled Item: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES
The Issue: ADVANCE(R) HA Coated tibial bases are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES
The Issue: Reported failure of the instrument. The retaining ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed
The Issue: The rear gradation scale was screen printed upside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one
The Issue: The rear gradation scale was screen printed upside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core
The Issue: Supplier design change contributed to a thinner plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT model #728306
The Issue: Supplier design change contributed to a thinner plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT Big Bore Oncology
The Issue: Supplier design change contributed to a thinner plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128
The Issue: Supplier design change contributed to a thinner plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Flex
The Issue: Supplier design change contributed to a thinner plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axiom 2.8 implants Sterile The Axiom REG implants are used
The Issue: Following a FDA inspection showing that the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axiom REG implants Sterile The Axiom REG implants are used
The Issue: Following a FDA inspection showing that the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PoleStar system (N20 / N30) Warning Lamps Control Box
The Issue: Medtronic Navigation is recalling certain components of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Image1 SPIES X-LINK Camera Control Unit (CCU)
The Issue: electrical interference issue when the Image1 SPIES
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The
The Issue: Data from internal studies suggests there may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System
The Issue: It is possible that that the selected Plan-of-the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3T 16ch Flex SPEEDER Coil
The Issue: There is a potential for higher than specified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in
The Issue: Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is
The Issue: Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part
The Issue: MultiQuant MD software where under certain conditions a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro
The Issue: MultiQuant MD software where under certain conditions a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.