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 12981–13000 of 38,428 recalls
Recalled Item: MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter
The Issue: The firm initiated a removal of certain batches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i Single Aspirate (SMN 11314044) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120 SAA AUTOSAMPLER (SMN 10374453) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i Dual Aspirate (SMN 11314045) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i Dual Aspirate (SMN 11314045) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical
The Issue: Investigations related to customer complaints received for particulate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120 DAA AUTOSAMPLER (SMN 10374454) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodisc C - prosthesis
The Issue: Centinel Spine learned through five customer complaints that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120 DAA AUTOSAMPLER (SMN 10374454) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAMBA Microcatheter. Packaged with protective sleeve over catheter
The Issue: The firm initiated a removal of certain batches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.