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 37421–37440 of 38,428 recalls
Recalled Item: Breath Tech
The Issue: volume leakage through the inlet valve during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirFlow
The Issue: volume leakage through the inlet valve during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab Premium Small Child Resuscitator
The Issue: volume leakage through the inlet valve during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stat-Check Resuscitator
The Issue: volume leakage through the inlet valve during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab Premium Small Adult Resuscitator
The Issue: volume leakage through the inlet valve during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100
The Issue: A fault in a high voltage relay in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034
The Issue: When doing a 3 Dimensional Rotational Angiography (3DRA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous
The Issue: Incorrect Screw (RC) included with NC CARES Abutment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Caremor Cliner"***Manufactured By Winco***Ocala
The Issue: Winco Mfg., LLC in Ocala, FL is recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala
The Issue: Winco Mfg., LLC in Ocala, FL is recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima XR220amx Mobile general purpose radiographic imaging of the human
The Issue: Software issue: a violation of 21 CFR 1020.31(a)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima XR200amx. Mobile general purpose radiographic imaging of the human
The Issue: Software issue: a violation of 21 CFR 1020.31(a)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chromovision High Definition (HD) Wireless Camera
The Issue: Defective camera: There is a possibility that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component
The Issue: When users selected "Left stenosis" in the "Graft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage:
The Issue: Digital Skin Mammography Marker separating from the backing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage:
The Issue: Digital Skin Mammography Marker separating from the backing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTec
The Issue: SenTec is recalling a number of V-Sign"2 Sensors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators
The Issue: On 07/09/2012, Apheresis Technologies, Inc. initiated a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage:
The Issue: Digital Skin Mammography Marker separating from the backing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IRISpec" CA/CB two-part urine chemistry control twin set
The Issue: The firm recalled after it received complaints of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.