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 5821–5840 of 38,428 recalls
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe CAGE GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Infinity Resection Adjustment Block
The Issue: Stryker has identified an issue that impacts specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe CAGE GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe REVERSE SHOULDER
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe GLENOID
The Issue: The packaging of these affected UHMWPE humeral liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: Beckman Coulter manufacturing discovered cracks around a threaded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:connect mobile app used in conjunction with t:slim X2 insulin
The Issue: During normal use, the mobile app version 2.7
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml
The Issue: Randox Laboratories has identified that Inorganic Phosphate in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIDEL InflammaDry MMP-9 Test
The Issue: There are two windows on the test device,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUIDEL InflammaDry MMP-9 Test
The Issue: There are two windows on the test device,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neria Soft Infusion Set
The Issue: Specific lots of Neria Soft Infusion Sets, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.