Complete FDA and NHTSA recall records dated in 2020, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on…
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles.…
Incorrectly installed base.
When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being…
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
The Streamline Navigation System taps have experienced binding with other devices.
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher…
The Streamline Navigation System taps have experienced binding with other devices.
KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur…
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles.…
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
The wall charger may not properly charge the infusion pump battery.
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
Frozen raw shrimp in import alert inadvertently released for distribution.
Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
Product may contain undeclared almonds.
Product is a choking hazard.
Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
