GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
The list names Abiomed, Dexcom, Medtronic, Siemens and others; its title and description give different months, so teams should check the dates at source.
Germany's medicines and devices regulator has listed an urgent field safety notice from EPflex Feinwerktechnik GmbH covering various guidewires, with details held in the manufacturer's advisory notice.
EOF has ordered the recall of every non-expired lot of the medical device 'Steriflush Syringes NaCl 0.9%', with affected lots listed in a table attached to the decision.
Health Canada reports a Type II national recall of Pendopharm's 25 mg and 50 mg diphenhydramine capsules after N-Nitroso-N-Desmethyl Diphenhydramine exceeded specification in seven lots.
The Dutch inspectorate has published a manufacturer field safety notice asking for preventive speed limiting on all Batec Handbikes platform 2 models, citing a new version of EN 12184.
The German regulator has posted an urgent field safety notice from Tontarra Medizintechnik covering a yellow ceramic-tip endoscope inner sheath, but the details sit in the manufacturer's own advisory.
Germany's regulator has posted a manufacturer advisory on the haematology reagent, but the defect and required user actions appear only in the attached Beckman Coulter notice.
The Danish Medicines Agency says Teva Denmark is facing delivery difficulties with Pinex 500 mg suppositories, with foreign packs permitted as a substitute under section 29(2) of the Medicines Act.
The Danish Medicines Agency lists delivery difficulties for paracetamol suppositories and points prescribers to foreign packs under section 29(2) of the Medicines Act.
The IGJ has posted an inspection report on Byondis B.V. following a supervisory visit in September 2026, but the listing does not give the findings.
Baxter Healthcare is voluntarily correcting certain TruSystem 7000 and 7500 tables after customers reported the main lift falling to its lowest position during use.
The Dutch health inspectorate has published a manufacturer warning: the Master List supplied with one Panocell-20 lot lists cell 6 as Jk(b+) when it is actually Jk(b-).
The Dutch inspectorate has published a manufacturer warning on Inpeco's FlexLab X lab automation system, citing possibly under-tightened electrical clamp connections on internal power cables.
IGJ has published a manufacturer warning after Beckman Coulter rotors used in Optima ultracentrifuges were found with an abnormal microstructure that may cause breakage in use.
SÚKL says falsified Mounjaro (tirzepatide) batches reported by Brazil's regulator have not been identified in the Czech market, and has asked operators to report any sighting immediately.
The Czech medicines authority says counterfeit Mounjaro detected abroad has not been traced in the Czech market, and asks operators to report any sighting of the listed batches immediately.
Lab testing of products from Shanghai ERP Peptide Biotechnology found bacterial contamination, prompting seizures from two Canadian web retailers and a request that the supplier stop selling into Canada.
Health Canada has published a Type II recall of Sysmex CN-3000 and CN-6000 analyzers after deposits on the sample arm B probe were found to risk reduced sample volumes.
The lid lock on some ROTOFIX 32A centrifuges may not engage securely, leaving the handle bar or latch open during a run, according to Health Canada.
Germany's regulator has posted a manufacturer notice from Life Technologies Holdings concerning software for the Ion Torrent Genexus Dx, but the public listing gives no detail of the problem.
Germany's regulator has posted a manufacturer notice for the V8 UltraCE, but its public description gives no detail on the problem, affected lots or required actions.
Germany's regulator has listed an urgent field safety notice from Intuitive Surgical covering a surgical scissors tip, but details of the issue sit only in the manufacturer's attached advisory.
Germany's BfArM has listed an Urgent Field Safety Notice from exocad GmbH covering exoplan, with the substance contained in the manufacturer's attached Advisory Notice.
The Danish Medicines Agency says quality problems have disrupted supply of Centyl med Kaliumklorid 2.5+573 mg coated tablets, with no end date given.
The Czech authority says selected lots of the two condom brands are being pulled from the market as a precaution, and advises consumers not to use them.
Austria's BASG says the revised Q&A allows higher acceptable intakes under a less-than-lifetime approach, extends CAPA timelines to seven years and adds a polymer-bag risk factor.
The IGJ has released a supervisory inspection report on Asclepius Pharma BV, but the material available gives no details of its findings or any required corrective measures.
The Health and Youth Care Inspectorate has posted its supervisory report on the Amsterdam donor sperm bank, though the notice itself does not reveal findings or any enforcement.
EOF has issued a supplementary recall covering batches 489588, 493006 and 497199 of Pedmarqsi 80 mg/ml solution for infusion, adding to an earlier recall.
Denmark's medicines agency says Aspen Nordic is struggling to deliver the lidocaine gel, with disruption expected from mid-July 2026 until the end of March 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.