Medical devices

Safety Information Regarding Possible Use of Counterfeit Biostimulator “Sculptra” New

Safety warnings | Medical devices | 31/07/2025
There is a potential health risk, as the safety and efficacy of the counterfeit products are not guaranteed. The contents of the counterfeit products are unknown.
Safety Information Regarding Possible Use of Counterfeit Biostimulator “Sculptra” Read more

Safety information regarding counterfeit hypodermic needles from the manufacturer Novo Nordisk A/S New

Safety warnings | Medical devices | 28/07/2025
The Federal Office for Safety in Health Care (BASG) has been informed about the counterfeit product "NovoFine Plus 32G 4mm" with the batch number NE61324-2 from the manufacturer Novo Nordisk A/S.
Safety information regarding counterfeit hypodermic needles from the manufacturer Novo Nordisk A/S Read more

Safety information regarding counterfeit dental resins from the manufacturer "Thermoplastic Comfort Systems, Inc." New

Safety warnings | Medical devices | 28/07/2025
The Federal Office for Safety in Health Care (BASG) has been informed that the following products have been counterfeited: - Unbreakable by TCS - IFlex by TCS - Karadent by TCS
Safety information regarding counterfeit dental resins from the manufacturer "Thermoplastic Comfort Systems, Inc." Read more

Safety information on the medical device Disinfection system with 3% peroxide

Safety warnings | Medical devices | 18/07/2025
The Federal Office for Safety in Health Care (BASG) warns against the disinfection system with peroxide 3 % from the manufacturer DISOP S.A. Only certain batch numbers are affected.
Safety information on the medical device Disinfection system with 3% peroxide Read more

Safety information regarding possible use of stolen dermal filler "Juvéderm"

Safety warnings | Medical devices | 26/06/2025
The products of the manufacturer "Allergan Aesthetics", a company of AbbVie, are facial fillers that are used in aesthetic medicine to treat wrinkles and to change the appearance of the face.
Safety information regarding possible use of stolen dermal filler "Juvéderm" Read more

Safety warning for medical devices of the manufacturer SEBBIN

Safety warnings | Medical devices | 14/04/2025
The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended.
Safety warning for medical devices of the manufacturer SEBBIN Read more

Report supply interruptions of medical devices

Medical devices | 02/01/2025
If a manufacturer expects that there will be interruptions in the supply of a medical device, it must report this to the competent authority in accordance with Article 10a of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). You can find more information here: https://www.basg.gv.at/fuer-unternehmen/medizinprodukte/hersteller#c24702
Report supply interruptions of medical devices Read more

Safety information on possible contamination of the non-sterile ultrasound gels „AquaUltra Clear“, „AquaUltra Basic“, and “Sono plus Ultraschall gel” of the manufacturer Ultragel Medical Kft.

Safety warnings | Medical devices | 11/12/2024
The Federal Office for Safety in Health Care (BASG) warns of a potential contamination of the non-sterile ultrasound gel “AquaUltra Clear” from the manufacturer Ultragel Medical Kft. According to the manufacturer, the affected batches can be identified by the LOT numbers 2024-04 to 2024-10.
Safety information on possible contamination of the non-sterile ultrasound gels „AquaUltra Clear“, „AquaUltra Basic“, and “Sono plus Ultraschall gel” of the manufacturer Ultragel Medical Kft. Read more

Safety information regarding the possible use of stolen ophthalmic products “MR Q SLT”

Safety warnings | Medical devices | 25/10/2024
The Austrian Federal Office for Safety and Health Care (BASG) was informed that the following two products were stolen during the shipping process in Switzerland.
Safety information regarding the possible use of stolen ophthalmic products “MR Q SLT” Read more
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