Complete FDA and NHTSA recall records dated in December 2020.
These records include useful source details for the selected month.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Missing solder battery connection, which could interrupt power of insulin pump.
Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm).…
Incorrect filter assemblies in IV administration set.
The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected…
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be…
Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in…
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be…
There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result…
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be…
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Product declared on shipping case does not match the inner packaged product. The inner packaged product contains Anchovy and anchovy is not an ingredient of the product identified on the…
Plastic pieces (1-2 cm) were discovered inside cans of tomatoes which were used to make two types of tamales.
Plastic pieces (1-2 cm) were discovered inside cans of tomatoes which were used to make two types of tamales.
The firm was notified via a consumer complaint that the product contained a long piece of metal.
Product recalled due to potential contamination of Salmonella.
The firm was notified via a consumer complaint that the product contained a long piece of metal.
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.
