Complete FDA and NHTSA recall records dated in 2019, 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.
Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could…
The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura…
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and…
Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample…
Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.
Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample…
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and…
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
During internal review is was discovered that the incorrect dressing was used in production of a vegetable wrap that does not declare soy as an ingredient or allergen.
Product may be contaminated with Listeria monocytogenes.
Product contains undeclared milk.
Product may be contaminated with Listeria monocytogenes.
An ingredient in the blended products has the potential to be contaminated with Salmonella.
An ingredient in the blended products has the potential to be contaminated with Salmonella.
Two lots of Sysco Classic Liquid Margarine have mislabeled interior packaging that identifies the product as Clear Canola Salad Oil STF which does not declare soy lecithin on the labeling.
Product may be contaminated with Listeria monocytogenes.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
Lack of Processing Controls.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
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.
