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 35061–35080 of 38,428 recalls
Recalled Item: Synergetics 25 gauge Soft Tip Cannula
The Issue: One lot of 25 gauge Soft-Tip Disposable Cannulas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 46-Series Medical Washer-Disinfectors
The Issue: Getinge Disinfection AB initiated a voluntary field safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry A1c_3 Calibrators
The Issue: Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H
The Issue: The possibility exists that 2.4 mm VA-LCP 2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Part Numbers 79-43903 (3cc)
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE
The Issue: Zimmer is initiating a lot specific voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Anastaflo Intravascular Shunt
The Issue: Edwards Lifesciences is recalling certain lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as
The Issue: These products are being recalled because they were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR
The Issue: These products are being recalled because they were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as
The Issue: These products are being recalled because they were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as
The Issue: These products are being recalled because they were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR
The Issue: These products are being recalled because they were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as
The Issue: These products are being recalled because they were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlas Spine Torque Limiting Handle 6N-m
The Issue: The device was not appropriately set to mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX Revolution Mobile X-Ray System
The Issue: During an audit, Carestream discovered a DRX-1 System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Pall AL6X Arterial Blood Line Filter
The Issue: Medical device used in cardiovascular procedures is defective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo¿ Advanced Perfusion System 1: 100/120V AC
The Issue: The operators manual does not fully describe the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 100/120V AC
The Issue: TCVS is taking action to update the Operators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo¿ Advanced Perfusion System 1 (APS1
The Issue: Terumo Cardiovascular Systems (TCVS) has become aware that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.