Coltene Whaledent ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts recall — FDA Z-0376-2019
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Complete FDA and NHTSA recall records dated in 2018, 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.
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic…
The reagent pack exhibits the potential for an increased frequency of calibration failures.
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature…
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Abnormally high INR test results with the affected CoaguChek test strips
Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result…
Incorrect package labeling identifying the device
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
There is a potential for comingling of the 43MM and 51 MM molds
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.
Potential for outer pouch sterile barrier to be compromised
The firm found what appeared to be plastic in the product.
Routine quality testing identified elevated levels of lead above applicable 2232 levels, which may pose potential health risks to a portion of the population.
Firm is recalling one lot of pistachios after customer tested product and had a positive result for Salmonella
The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
During FDA inspection it was found that soy oil was not declared on package label
During FDA inspection it was found that soy oil was not declared on package label
During FDA inspection it was found that soy oil and coconut was not declared on package label.
The apple juice concentrates contain high levels of inorganic arsenic. The firm is recalling lots that were distributed for use other than fermentation (i.e. alcohol or vinegar).
Positive result for Salmonella received while investigating to determine supplier of direct customer's positive findings also for Salmonella
Frozen non-ready to eat Alaskan Salmon Bites, Kroger brand, are recalled due to potential contamination with Listeria monocytogenes or Salmonella in vegetables ingredient.
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.