Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Sub-potent drug: assay test result below specifications at 9-month timepoint.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
BMW of North America, LLC (BMW) is recalling certain 2023 X1 xDrive28i, X1 M35i vehicles. On the second-row outboard seats, the seat belts may have been pinched by an interior trim panel…
Subaru of America, Inc. (Subaru) is recalling certain 2023 Ascent vehicles equipped with 20-inch wheels. The internal tire bead may have been damaged during the wheel mounting process.
BMW of North America, LLC (BMW) is recalling certain 2023 X5 sDrive40i, X5 xDrive40i, X5 M50i, X5 M and X5 xDrive45e vehicles. The head restraints for the second-row outboard seats may have…
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for…
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid…
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Presence of misleading label statements on the product label.
Presence of misleading label statements on the product label.
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular…
Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the…
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated…
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Presence of misleading label statements on the product label.
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for…
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Sterility; Steril surgical procedure packs contain incomplete seals.
Presence of misleading label statements on the product label.
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