Complete FDA and NHTSA recall records dated in September 2020.
These records include useful source details for the selected month.
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680…
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result…
Unit boxes not properly sealed
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is…
Unit boxes not properly sealed
Unit boxes not properly sealed
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307…
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel…
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
Reagents were shipped to customers after the Use by data indicated on its labeling.
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307…
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680…
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by…
Popcorn ingredient was recalled due to foreign matter: tempered glass between 3 mm and 7 mm in size
May contain undeclared milk
May contain undeclared milk
Popcorn ingredient was recalled due to foreign matter: tempered glass between 3 mm and 7 mm in size
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.
