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Medical devices
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18/02/2026
These tests for self-testing for the detection of sexually transmitted diseases (STDs) from the manufacturer Genesign Biotech (XIAMEN) Co, Ltd are also marketed under the brand name JAL Medical (Singapore) Pte. Ltd.
These products do not bear a CE mark, which means that they do not fulfil the requirements for in-vitro diagnostics. The BASG has information that the manufacturer has not carried out the required EU conformity assessment procedure. These products are therefore not marketable on the EU market.
Safety warnings
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Medical devices
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10/02/2026
The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Needleless Airtight Infusion Connector Protector" from the manufacturer "Zhejiang Runqiang Medical Instruments Co., Ltd.".
Safety warnings
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Medical devices
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12/01/2026
The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Sculptra" from the manufacturer "Q-Med AB".
Safety warnings
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Medical devices
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18/12/2025
The Federal Office for Safety in Health Care (BASG) warns of non-conforming subcutaneous and absorbable PDO threads, marketed as “ARIEL PDO Threads”, along with associated cannulas intended for mechanical tightening of loose and sagging skin (facelifting).
Medical devices
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02/12/2025
The BASG has announced that the first four modules of the European Database on Medical Devices (EUDAMED) will be mandatory to use as from 28 May 2026.
Safety information regarding the counterfeit medical device "Nasal Cannula, Luer-Lock F, PVC, adult"
Safety warnings
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Medical devices
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10/09/2025
The Federal Office for Safety in Health Care (BASG) warns against counterfeit medical devices. The product "Nasal Cannula, Luer-Lock F, PVC, adult (REF 1.4.3.3.5)" has been counterfeited.
It cannot be ruled out that this product is also on the Austrian market. Counterfeit medical devices have no or an unpredictable effect and are to be classified as dangerous. They must not be used under any circumstances.
Safety warnings
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Medical devices
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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 warnings
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Medical devices
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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 warnings
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Medical devices
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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 warnings
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Medical devices
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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.