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 34081–34100 of 38,428 recalls
Recalled Item: 7" (18 cm) Appx 0.31 ml
The Issue: ICU Medical is recalling certain lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8" (20 cm) Appx 0.51 ml
The Issue: ICU Medical is recalling certain lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10" (25 cm) Appx 0.38 ml
The Issue: ICU Medical is recalling certain lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Horizon Medical Imaging
The Issue: Images may be archived to an incorrect or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA
The Issue: The accuracy is out of specification for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Power Input: 100-240VAC
The Issue: The locking mechanism that is intended to hold
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound System
The Issue: The user interface assembly on the ACUSON SC2000
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE
The Issue: Siemens confirmed an overall average positive bias of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE /IMMULITE 1000 Systems TIE Total IgE
The Issue: Siemens confirmed an overall average positive bias of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND)
The Issue: Siemens Healthcare Diagnostics confirmed over-recovery of samples with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND)
The Issue: Siemens Healthcare Diagnostics confirmed over-recovery of samples with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orbit soft Infusion sets
The Issue: Perrigo was notified by our supplier, Ypsomed AG,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Monitor B850
The Issue: There is a potential for communication loss associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compensator Slider Lambda 6x20 component (part number 473704-0000-000)...
The Issue: Carl Zeiss Microscopy, LLC has recalled the Compensator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision
The Issue: for unexpected heating of the transformer mounting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray
The Issue: During internal testing, the Brilliance CT Big Bore
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIFY¿ SixCess 270FP Challenge Pack
The Issue: STERIS has identified that the outer shipping package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT
The Issue: Three problems were reported to the firm: When
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation
The Issue: ITC has determined that some Citrate APTT cuvettes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIATELE TELEMETRY TRANSMITTER
The Issue: The AriaTele Model 96281 with SpO2 monitoring Option
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.