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 10061–10080 of 38,428 recalls
Recalled Item: MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER
The Issue: for the suction catheter to come apart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER
The Issue: for the suction catheter to come apart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER
The Issue: for the suction catheter to come apart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FABCO ORS DENTAL ROLLS
The Issue: Sterility with new cotton source not validated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Flow Controller Extension Set with Needleless Y-Site
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Flow Controller Extension Set with Needleless Y-Site
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Randox Serology I Positive Control contains the following analytes
The Issue: ***Update** :HBsAg analyte is also Non-Reactive on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Extension Set with 2 Needleless Y-Site
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Extension Set with 4-way stopcock
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MaxGuard Extension Set
The Issue: Administration set, and extension set product labels list
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5 IN (17 cm) APPX 0.78 ml
The Issue: Due to a manufacturing defect which results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroClave Clear Neutral Connector
The Issue: Due to a manufacturing defect which results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6" (15 cm) Appx 0.85 ml
The Issue: Due to a manufacturing defect which results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroClave Clear Neutral Connector. A bidirectional connector used as an
The Issue: Due to a manufacturing defect which results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8.5" (22 cm) Appx 0.85 ml
The Issue: Due to a manufacturing defect which results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5" (17 cm) Appx 0.84 ml
The Issue: Due to a manufacturing defect which results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.