An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc.…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a…
The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or…
Class IIFDA: OngoingFisher & Paykel Healthcare, Ltd.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through…
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and…
Class IFDA: OngoingBoston Scientific Corporation
How to use this monthly recall archive
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.