Complete FDA and NHTSA recall records dated in April 2019.
These records include useful source details for the selected month.
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Labeling: Label mix-up
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Presence of Particulate Matter; glass particulates
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2019 Lexus ES vehicles. These vehicles are equipped with a driver knee air bag assembly mounted to the lower…
BMW of North America, LLC (BMW) is recalling certain 2019 X3 sDrive30i, X3 xDrive30i, X3 M40i, and X4 M40i vehicles. The instrument panel assembly may have been improperly manufactured,…
Volkswagen Group of America, Inc. (Audi) is recalling certain 2018-2019 Audi Q5 and SQ5 vehicles. The brake master cylinder casting may be too short.
Ford Motor Company (Ford) is recalling certain 2015-2019 Ford F-150 and 2017-2019 Ford F-250 Super Duty, F-350 Super Duty, F-450 Super Duty, and F-550 Super Duty pick-up trucks equipped…
Breach in the sterile barrier pouch may compromise sterility of the device.
Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In…
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding…
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding…
Breach in the sterile barrier pouch may compromise sterility of the device.
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor
On-X Valve was mislabeled with the incorrect serial number.
Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes…
An error in the assignment of the control range pH in Blood Gas Control
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
