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The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (BMG). It is headquartered in Bonn, Germany. [1] Its president is Karl Broich. [2]
The recall applies to Life2000 ventilators with the product code MS01-0118 that have the attached battery charger dongle, and were distributed in the U.S. from Aug. 21, 2023 to April 2, 2024 ...
About 10,655 devices, which were distributed between Oct. 26, 2022 and July 17, 2023, have been recalled by the company. B. Braun Medical did not immediately respond to a Reuters request for comment.
Politico reported that the number of the most serious medical device recalls, as classified by the FDA, rose by nearly 50% last year, to 102. In July 2024, Philips sent an urgent recall due to ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
The FDA has announced over 20 recalls across the U.S., including food items, cosmetics, drugs, dietary supplements, and medical devices.
Vyaire started the recall process on Dec. 6 last year and has recalled over 6.6 million devices in the United States. The recalled devices were either without a manufacturing date or were ...
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