SYSTANE recall — FDA D-0491-2026
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
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.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Tesla, Inc. (Tesla) is recalling certain 2017, 2021-2023 Model 3, 2020-2023 Model Y, 2021-2023 Model S, and Model X vehicles operating software version 2026.8.6. The rearview camera image…
Gulf States Toyota, Inc. (GST) is recalling certain 2026 4Runner vehicles. The load carrying capacity modification label states the incorrect load carrying capacity. As such, these vehicles…
Braun Corporation (Braun) is recalling certain 2026 Ram ProMaster vehicles. The rear bench may have only two of four seat legs installed. As such, these vehicles fail to comply with Federal…
Unapproved design changes to the products outside of the 510(k) clearance.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a…
Unapproved design changes to the products outside of the 510(k) clearance.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized…
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and…
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