Complete FDA and NHTSA recall records dated in November 2018.
These records include useful source details for the selected month.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power…
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
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.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
