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 35901–35920 of 38,428 recalls
Recalled Item: PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid
The Issue: Review of validation information and customer complaints which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac
The Issue: Newport Medical Instruments is conducting a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosure Ratchet Driver
The Issue: Driver does not meet specification, oversized. Driver may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosure Driver
The Issue: Driver does not meet specification, oversized. Driver may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: remel RapID Yeast Plus System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use
The Issue: solution leakage at the interface of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use
The Issue: solution leakage at the interface of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848
The Issue: An LPC Fine Mesh Cassette failed to stay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuietCare. Intended for use in monitoring the environmental conditions and
The Issue: Customers at 4 facilities reported receiving duplicate alerts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PTS PANELS
The Issue: Internal investigation demonstrated under-recovery for glucose when tested
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuietCare-Networked. Intended for use in monitoring the environmental...
The Issue: Customers at 4 facilities reported receiving duplicate alerts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas¿ 8000 modular analyzer series software version 03-01
The Issue: When using the cobas e 602 module, Diluent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExoShape Soft Tissue Fastener 12 mm x 30 mm REF
The Issue: Expiration date on the patient label and date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software correction applies to customers who use the RT Therapist
The Issue: Software update to fix multiple safety related issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOSHIBA Kalare Diagnostic X-Ray System K110785
The Issue: Firm initiated recall because when radiographic conditions with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products CK-MB Calibrators
The Issue: Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is distributed by Zimmer (Warsaw
The Issue: Various reciprocating and oscillating saw blades were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.