Class 2 Medicines : Norgine Pharmaceuticals Limited, Pedmarqsi 80
OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Devices supplied without valid UKCA/CE conformity markings or Recall: The MHRA has become aware of a number
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryUnited KingdomPublishedAugust 10, 2026Last updatedAugust 10, 2026Official source last checkedSeptember 9, 2026 at 1:48 PM UTC
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR).
Hazard
The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR).
What consumers should do
for Healthcare Professionals: review whether your organisation holds, uses or supplies any of the devices listed in this DSI immediately stop using and supplying any identified product(s) and quarantine all remaining stock identify and use alternative compliant products retain affected devices pending further advice from the MHRA alert the MHRA that you are in possession of an affected device via devices.compliance@mhra.gov.uk quoting the DSI reference number (DSI/2026/007) providers should ensure all relevant members of staff receive this Device Safety Information (DSI) and that they understand the
Official recall notice
Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: August 10, 2026
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