Medicine and device safety: 20 official communications for 5–6 November 2026
- 06-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
This review covers 20 official medicine, device and pharmacovigilance communications. It distinguishes new risk-management information, new local notices about known issues, and newly published guidance or summaries. Website publication dates are distinguished from underlying document and action dates.
Duvyzat (givinostat): interim monitoring advice
Following reports of deaths outside the UK in patients with Duchenne muscular dystrophy taking Duvyzat, MHRA issued interim advice pending independent review. Additional advice covers 24-hour ambulatory ECG monitoring at baseline and on a stable dose, plus potassium, magnesium and calcium checks every two weeks for the first two months, at month three and every three months thereafter. Existing warnings and routine ECG guidance remain applicable. No UK deaths have been reported; patients should continue prescribed treatment and attend monitoring. These are interim recommendations rather than final product-information changes.
Web publication: 2026-11-05. Underlying document/action: 2026-11-05. MHRA DSU vol20 issue4:1
MHRA — official source · Primary attachment 1 · Primary attachment 2
Sandoz co-amoxiclav: incorrect dosing table
The defective SmPC section 4.2 table for the 250/62.5 mg/5 mL suspension instructed approximately twice the recommended dose. All batches are affected by the documentation error; powder quality is unaffected. MHRA advises against using that table and provides corrected information in Annex 1. A same-day correction confirms the strength as 250/62.5 mg/5 mL. Patients should follow their prescription and seek medical advice if a higher dose was taken and symptoms occur.
Web publication: 2026-11-05. Underlying document/action: 2026-11-05. EL(26)A/46;DMRC41234128
Aspire tropicamide: three batches with an incorrect expiry date
MHRA announced a pharmacy/wholesaler recall of tropicamide 1% eye-drop batches E941A, E941B and E941C. Packs state 30 April 2027; the correct expiry is 31 October 2026. Stop supply, quarantine remaining stock and return it through the supplier process. No adverse incidents due to this defect have been reported. MHRA advises patients holding these batches to continue using the drops and contact their prescriber for a replacement.
Web publication: 2026-11-05. Underlying document/action: 2026-11-04. EL(26)A/47;DMRC41341621
StatStrip Ketone: potential delays in test results
The Type II recall covers ketone-strip lots 2224295249 and 2226117249, catalogue 66841, because of increased quality-control test failures. Health Canada states that patient whole-blood testing performance is unaffected; the recall aims to prevent delays in ketone results. Identify and discontinue the affected lots and follow the recall instructions.
Web publication: 2026-11-05. Underlying document/action: 2026-10-23. RA-82918
Olympus reusable HF cables: service-life reminder
Following the earlier WA00014A action, Olympus identified 19 additional models that may experience the same failure. The new Canadian Type II notice lists reusable HF-cable models and reminds customers of the instructions and service-life cautions intended to reduce cable-failure likelihood. Obtain complete serial-number information and further instructions from the manufacturer.
Web publication: 2026-11-05. Underlying document/action: 2026-10-16. RA-82911
Brainlab Cranial EM: registration issues in neonates and infants
With Cranial EM and Universal Atlas 6.0, surface registration in neonates and infants may fail or produce unusable results. Accepting an inaccurate registration can cause navigation errors and serious injury. Brainlab advises planning an appropriate backup method and verifying accuracy before proceeding. Neonates and infants are not expressly included in the device indications. Customer contact for the software update is planned from December 2026, subject to regional availability.
Web publication: 2026-11-05. Underlying document/action: 2026-10-22. R2633372;CAPA-20260507-003045
FIX-RAL-555: lot R98203 and staining reliability
RAL Diagnostics describes an abnormal colour in reagent lot R98203. Section 2.2 says unreliable staining may compromise interpretation and delay diagnosis; section 2.4 separately states no risk to patients or users. Identify, quarantine and stop using affected products, and follow the exchange/destruction procedure by 30 November.
Web publication: 2026-11-05. Underlying document/action: 2026-10-21. R2632261;FSN/FSCA26/179
6008 CAREsystem: ultrafiltration-profile error
Fresenius reports that changing ultrafiltration time while a UF profile is running can trigger a protective pump stop. Potential consequences include reduced ultrafiltration or dialysis dose, and blood loss if treatment is ended early without blood restitution. Standard UF mode is recommended temporarily where clinically appropriate. If profiles are essential, follow the notice’s stop, change, reselect and restart sequence. A software correction is planned for the end of Q2 2027.
Web publication: 2026-11-05. Underlying document/action: 2026-10-28. R2632863
Philips Spectral CT: software issues and risk controls
Philips lists version-specific issues involving image artefacts, incorrect slice thickness and unintended movement. Potential consequences include repeat scanning or misinterpretation. Affected sites should apply the notice’s issue- and version-specific instructions pending software correction. Philips reports no associated harm or injury reports as of July 2026.
Web publication: 2026-11-05. Underlying document/action: 2026-10. R2625216;2026-PD-CTAMI-003UFSNRevB
Horizon DXA W/WI: replacement of unvalidated VGA cables
Hologic reports that certain systems were supplied without validated VGA cables, potentially increasing electromagnetic interference, particularly for people with active implantable medical devices. A service visit replaces the cable; the system need not be returned. Until correction, affected systems should not be used or operated by patients or users with these implants. No injury reports were recorded as of 1 October. Health Canada also published related notice RA-82912 on 5 November.
Web publication: 2026-11-05. Underlying document/action: 2026-10-23. R2631664;FA-00311;MISC-12106-FRA-901Rev001
ANSM — official source · Primary attachment 1 · Primary attachment 2
Intersurgical: recall of specified breathing circuits
Insufficient bonding of soft connectors may allow a breathing-circuit disconnection, compromising ventilation and causing hypoxia. The notice describes potentially severe outcomes, including death, depending on the situation and time to restore ventilation. Match exact references and lots against the annex, quarantine affected devices and follow the recall procedure. The action does not apply to every circuit made by the manufacturer.
Web publication: 2026-11-05. Underlying document/action: 2026-10-28. R2632860;FSCA632673
Kélis Medical: new Steriflush communication
Kélis Medical’s notice covers all unexpired lots of three specified Steriflush references. This is a new distributor communication concerning the existing mandatory action following an INFARMED inspection. The letter reports no related serious incidents or adverse events. Stop use, reconcile stock, return affected products and acknowledge receipt as instructed.
Web publication: 2026-11-05. Underlying document/action: 2026-10-20. R2631678;FSN2026/02;FSCA2026-01
S.B.M. FIXIT and ComposiTCP: suture-breakage risk
Potential sharp edges on the screwdriver carrying certain premounted implants may break sutures during surgery, prolong the procedure or require a change in technique. The recall concerns only unimplanted devices from the listed lots. Stop use, isolate stock and contact the manufacturer. No specific follow-up is recommended for patients already implanted, because the identified risk is limited to the intraoperative phase.
Web publication: 2026-11-05. Underlying document/action: 2026-10-27. R2632135;FSN/FSCA-26-0147
OdySight: missing test results and notifications
The ANSM-hosted letter template states that since December 2024 approximately 1% of visual-acuity tests were not transmitted to the medical database or analysed, so some deterioration alerts were not issued. Clinicians are advised to review results and consider an earlier appointment. Missing-test import is planned from 10 November and a software fix by 15 December. The published attachment is an undated letter template.
Web publication: 2026-11-05. R2632638;VIG-2026-001
Wayrilz: clarification of adolescent safety data
EMA published procedure information updating the product information based on LUNA 3. Data for ITP patients aged 12 years and older describe an adverse-reaction profile generally similar to adults, but incompletely characterised because of limited data. The serious-infection warning refers to adult trial patients. This data update does not establish a new paediatric indication; the authorised indication remains for adults.
Web publication: 2026-11-05. Underlying document/action: 2026-10-16. EMA/VR/0000341281
EMA — official source · Primary attachment 1 · Primary attachment 2
Voriconazole Accord: mavacamten interaction information
EMA’s 5 November procedure records addition of mavacamten interaction information to Voriconazole Accord SmPC section 4.5 and the package leaflet, following the reference product Vfend. Other contraindications shown in the history belong to earlier procedures and are not presented as new changes.
Web publication: 2026-11-05. Underlying document/action: 2026-11-05. EMA/VR/0000368652
EMA — official source · Primary attachment 1 · Primary attachment 2
Ogsiveo: postmarketing data updated in the RMP
The Ogsiveo RMP update covers the new marketing-authorisation holder, treatment options, postmarketing exposure and data characterising the important potential risk of adverse effects on female fertility. This entry does not establish a new confirmed risk or frequency. Earlier hypersensitivity and eye-disorder changes are not dated as 5 November updates.
Web publication: 2026-11-05. Underlying document/action: 2026-11-05. EMA/VR/0000373359
EMA: revised nitrosamine questions and answers
Revision 24 adds question 23 on other N-nitroso compounds and question 24 on less-than-lifetime nitrosamine exposure, with related changes to questions 4, 10, 20 and 22, including interim limits during CAPA implementation. Applicability and restrictions depend on compound category and administration duration; this is not blanket permission to increase any limit. It is a guidance update rather than a product-specific recall.
Web publication: 2026-11-05. Underlying document/action: 2026-11-03. EMA/409815/2020Rev24
SEC: newly linked step-by-step reporting instructions
A newly linked SEC pharmacovigilance document explains AISF reporting by healthcare professionals, patients and applicants, the six form tabs, required fields, attachments and the resulting report number and Form 137/o. Registration is not required to complete the web form. This is a reporting-instruction update rather than a product signal. The document is undated.
No separate document number shown
NMPA/CDR: medical-device vigilance bulletin 236
The newly published Chinese bulletin summarises five September–October 2026 FDA communications concerning StatStrip result identification, BD Alaris performance, VentStar Resus Neo cracks, Imager II tip detachment and Abiomed heart-pump controllers. It is a new review publication about earlier foreign actions, not five new Chinese regulatory decisions; underlying action dates remain in September–October.
Web publication: 2026-11-05. Underlying document/action: 2026-11-05. 2026No10;total236
For QPPV, LQPPV and LCPPV professionals, these communications support assessment of local applicability, risk-minimisation follow-up, safety-information maintenance and reporting procedures. Role definitions and obligations vary by jurisdiction.