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.
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode.…
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware…
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode.…
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration…
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
The product contains pecans which are not declared on the product labeling.
Firm was notified by manufacturer in Italy that Pistachio Gelato contained the color sodium copper chlorophyllins (SCC), which is not authorized by FDA as a color additive for this product…
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