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 16641–16660 of 38,428 recalls
Recalled Item: Atellica CH 930 Analyzer
The Issue: On the Atellica CH 930 Analyzer, when scanning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ElectroTek Temporal Sensor Cable Gold - Long Length
The Issue: for one of the four temporal electrode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ElectroTek Temporal Sensor Cable Gold - Long Length
The Issue: for one of the four temporal electrode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchromed II programmable pump
The Issue: There is a potential for the presence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Incubator Carestation
The Issue: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed infant warmer
The Issue: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Incubator infant warmer
The Issue: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed Carestation
The Issue: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS
The Issue: Due to an error on the packaging line,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PolarCath Balloon Catheter consists of a coaxial catheter shaft
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS
The Issue: Due to an error on the packaging line,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4plus Streptavidin HRP Label
The Issue: Firm has identified product has no staining. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panther Fusion Extraction Reagent-S
The Issue: Reagent component included in flu test kit may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.5mm Aresenal Screw Drill Bit
The Issue: Labeling Error; specifically, drill bits from lots #
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metasul Femoral Heads
The Issue: Non-highly polished implants may adhere to the LDPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF Humeral Stem
The Issue: Non-highly polished implants may adhere to the LDPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connection Screw for NCB Plate
The Issue: Non-highly polished implants may adhere to the LDPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERIARTICULAR PLATES - FEMUR
The Issue: Non-highly polished implants may adhere to the LDPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Knee Systems
The Issue: Non-highly polished implants may adhere to the LDPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prox Lat Tib Lock Plate and Dist Med Tib Lock
The Issue: Non-highly polished implants may adhere to the LDPE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.