GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
Beaver-Visitec International has recalled certain Mini Blades units after finding an intermittent "open seal" condition that means sterility cannot be guaranteed, Health Canada reports.
Nine General Procedure Tray configurations are affected after Becton Dickinson asked for discontinuation of infusion sets used with the BD Alaris pump module model 8100.
A technical investigation prompted by a customer complaint found certain lots of Remel's R30166901 reagent fail to react with the ATCC13102 control strain within the 60 seconds set in the instructions for use.
IGJ has posted a manufacturer warning on the Vercise Neural Navigator 5 software, centred on how an inaccurate battery estimate could lead to interrupted stimulation.
The German regulator has published a PTW Freiburg field safety notice on Track-it, a radiotherapy treatment planning product, but the specifics sit in the manufacturer's attached advisory.
Germany's BfArM has listed an urgent field safety notice from Richter Rubber Technology Sdn Bhd on condoms, but the public entry gives no details of the problem.
The German regulator has listed an urgent field safety notice from DH Healthcare GmbH for ORBIS Medication, but the public listing gives no details of the problem or required actions.
Portugal's medicines and health products authority says registration of devices placed on the market before 28 May 2026 must be finished by 28 November, with a notified body deadline following in 2027.
Ravimiamet says devices placed on the market before 28 May 2026 and still being supplied must be registered in EUDAMED by 28 November 2026.
DKMA says production problems at STADA Nordic ApS are disrupting supply of Aprepitant 'Stada' 125+80 mg hard capsules, with disruption forecast from late October 2026 to early March 2027.
The Danish Medicines Agency reports production problems at STADA Nordic ApS, with supply of the 80 mg hard capsules expected to be affected from early November 2026 to early March 2027.
The Danish Medicines Agency lists quality problems as the reason for disrupted supply of Elanco's veterinary Galliprant 100 mg tablets, expected to last until mid-February 2027.
A typographical error on the front of the carton misstates the hydrochlorothiazide strength as "12. mg"; the MHRA says the tablets are unaffected and supply should continue.
Germany's regulator has posted an urgent field safety notice from Urotech GmbH on its Renodrain Nephrostomie device, but the public listing gives no details of the problem.
Germany's medicines and devices authority has posted a manufacturer field safety notice for various AMOR Gummiwaren condom models, with details held only in the attached advisory.
The Danish Medicines Agency reports production problems affecting SomaKit TOC 40 microgram, with disruption expected from the start to the end of November 2026.
Germany's regulator has posted a manufacturer advisory on the Vanta INS, but the published listing does not describe the issue or the actions required.
Germany's regulator has listed a manufacturer safety notice for the deep brain stimulation programming software, but the public entry gives no detail on the issue or required actions.
Germany's medicines and devices regulator has listed a manufacturer notice for the Shockwave Reducer, but the nature of the problem is only in the attached Advisory Notice.
Germany's medicines and devices authority has posted an Urgent Field Safety Notice from Bolton Medical covering three aortic stent-graft products, with the manufacturer's Advisory Notice attached.
IsoTis OrthoBiologics is voluntarily removing specific Accell Connexus lots in Canada after possible particulate contamination linked to contact between a ball spring and the mixing container during manufacture.
Carestation 850 and 850c systems can deliver a lower concentration of anaesthetic agent than intended, according to a Health Canada recall notice for Datex-Ohmeda, Inc.
IGJ says an inspection found the products were not classified as medical device accessories and were sold without correct labelling or a compliant IFU, risking use errors.
A technical investigation prompted by a customer complaint found certain lots of Remel's 2ml Neisseria meningitidis Gp C reagent do not meet instructions-for-use performance criteria.
Daniel Lee admitted conspiracy to commit health care fraud and money laundering over claims for unnecessary prescription drugs and adult day care services never delivered, the US Justice Department said.
Italy's medicines agency has published a document for companies on referencing bibliographic sources in promotional materials, via its Office for Medicines Information and Advertising Oversight.
France's medicines agency has issued a temporary recommendation after Sanofi production problems disrupted European supplies of the rifampicin/isoniazid combination, and has capped distribution.
Italy's medicines agency has issued a document from its advertising oversight office setting out how companies should use bibliographic references in promotional materials for medicinal products.
Denmark's medicines agency lists Novartis Healthcare's fingolimod 0.25 mg hard capsules as affected by manufacturing difficulties, with the notice last updated on 10 November 2026.
The Danish Medicines Agency reports ongoing supply difficulties for Ferring's desmopressin nasal spray Octostim 1.5 mg/ml, with a stated expected period running to early February 2027.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.