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.
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently…
The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement…
There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware…
The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing…
A component of the kit was found to contain bacterial contamination.
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
A potential commingle that could result in the product in the package not matching the product on the outer label.
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct…
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton…
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for…
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
The secondary packaging is labeled with an incorrect expiration date.
A potential commingle that could result in the product in the package not matching the product on the outer label.
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
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