Medicine and device safety: 14 communications for 3–4 November 2026
- 04-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
This review covers 14 newly posted or updated official safety and pharmacovigilance communications. A local communication about a known issue is distinguished from a new safety signal. The date of a web publication may differ from the date of the underlying action or document.
IPIDACRINE VELPHARM: batch 0060626 recall
Roszdravnadzor reports a manufacturer recall of batch 0060626 of IPIDACRINE VELPHARM 5 mg/mL, 1 mL solution for intramuscular and subcutaneous injection. Stability testing identified nonconformity with the related-substances specification. Supply-chain participants are asked to report measures taken to withdraw the batch and prevent harm. The letter does not describe adverse-reaction cases.
Web publication / document: 2026-11-03 / 2026-11-03. 01И-1279/26.
Caelyx: French communication on vial closure defect
ANSM published Baxter’s letter concerning batch 5I021E, expiring 30 April 2027. The crimp and stopper may detach during opening and compromise sterility. Inspect before and after removing the flip-off cap; do not use vials with visible defects. Vials without visible defects may be used as intended. Baxter reports no related adverse events and describes the overall risk as low. This is a new French communication about an already known issue.
Web publication / document: 2026-11-03 / 2026-10-30. No document number stated.
Innoset: action for sets containing Steriflush syringes
ANSM published separate Innoset notices for mainland and overseas users of care sets containing Steriflush NaCl 0.9% syringes. Stop using affected syringes, reconcile lots and follow the stated component-replacement procedure. Both notices provide for use of the sterile subassembly with a separately supplied syringe, following their respective appendix. Other set components are not declared defective. The action follows regulatory inspection findings, rather than reported clinical incidents.
Web publication / document: 2026-11-03 / 2026-10-20. R2631690;FSN2026-01A/01B;FSCA2026/02.
ANSM — official source · Primary attachment 1 · Primary attachment 2
BVI Mini-Blade and Lamellar Blade: selected-lot recall
BVI is recalling the ophthalmic blade lots listed in its appendix because open seals may compromise sterility and increase infection risk. Check stock, quarantine affected products, stop use and distribution, and arrange return as instructed. The notice reports one complaint and no related adverse events.
Web publication / document: 2026-11-03 / 2026-11-02. R2632865;FA-26-004.
Audiolyser ADL Connect: update addresses excessive sound output
FIM Medical reports two excessive-output events at 250 Hz caused by a calibration-data writing error. Discomfort and tinnitus may occur; no permanent injury is reported. The notice specifies Audiowin 01.03.00 and firmware 02.00.00, an interim check, and acknowledgement by 20 November 2026. Follow the official letter for the check and handling of a blocked frequency.
Web publication / document: 2026-11-03 / 2026-10-22. R2632057;FSCA-2026-01.
Sysmex CN: risk of falsely low results
Sysmex reports deposits on sample-arm probe B that can reduce sample volume and produce falsely low results. Seven complaints and no patient harm were reported as of 15 October. Clean immediately before further routine use, then at least weekly or every 16,000 tests, whichever comes first, and document maintenance. Consider retrospective review where there is evidence of impaired sampling; normal quality-control results alone do not exclude an effect on patient results.
Web publication / document: 2026-11-03 / 2026-10. R2632263;FSCA2606.
SOLTIVE: correction identifies seven unaffected lots
Olympus corrected manufacturing cut-off dates for four SOLTIVE models. Seven lots—PW311589, PW311591, PW311646, PW311636, PW311637, PW311594 and PW311595—already contain the new material and are outside this action; they should not be returned. This clarifies the scope of an earlier thermal-event-related recall, rather than introducing a new signal or cancelling the entire action. Instructions for other affected products remain applicable.
Web publication / document: 2026-11-03 / 2026-10-06. R2627560;QILFY25-089-F-1.
ANSM — official source · Primary attachment 1 · Primary attachment 2
Sodium citrate: potential bag leaks, without a lot recall
Health Canada warns of potential leaks in Fresenius Kabi sodium citrate anticoagulant bags for apheresis, with possible solution loss, procedure interruption and microbial contamination. Appendix 1 lists 17 lots. In consultation with the regulator, these lots are not currently being recalled because pre-use checks are available and plasma-collection continuity is considered. Inspect every bag regardless of lot as instructed; discard leaking or damaged bags or non-clear solution. The company reports no related adverse events or contamination complaints. The solution is not for direct intravenous infusion.
Web publication / document: 2026-11-03 / 2026-11-03. RA-82902.
Health Canada — official source · Primary attachment 1 · Primary attachment 2 · Primary attachment 3 · Primary attachment 4
Medsafe: risks of unapproved peptide products
Medsafe warns about uncertain contents, quality, safety and dosing risks of unapproved peptide products. As of 21 October, New Zealand had 10 reports; five noted hospitalisation or came from a hospital. Most concerned women who believed they were using retatrutide; this does not verify the product contents. Gastrointestinal symptoms predominated, and half mentioned possible cardiovascular effects. Testing one sample does not establish the safety of all vials.
Web publication / document: 2026-11-04 / 2026-11-04. No document number stated.
Swissmedic Vigilance News edition 37
Swissmedic published edition 37, covering passive hepatitis B antibody transfer after IVIg, persistent B-cell depletion following rituximab, and dose-dependent enzyme induction by dexamethasone. It also discusses central access to mandated information material and safety reporting. This is an informational bulletin with case observations, rather than a standalone mandatory label change or proof of causality for every case.
Web publication / document: 2026-11-03 / 2026-11. Edition37;November2026.
Bildyos: osteonecrosis-of-the-jaw information update
EMA published a procedure entry accepting updated osteonecrosis-of-the-jaw information in section 4.8 and patient-reminder-card information in Annex IID for Bildyos. It follows an already approved change for reference product Prolia and is not presented as a new global signal.
Web publication / document: 2026-11-03 / 2026-11-03. EMA/VR/0000382955.
Sycrest: change to the RMP safety-concern list
EMA recorded a Sycrest RMP change removing all entries from its safety-concern list following PSUSA/00000256/202508. This change to the regulatory RMP list does not mean that the medicine has no adverse reactions, contraindications or other risks.
Web publication / document: 2026-11-03 / 2026-11-03. EMA/VR/0000381110;PSUSA/00000256/202508.
Truqap: reasons for withdrawal of a new-indication application
EMA published an explanation of the withdrawn application to extend Truqap to PTEN-deficient metastatic hormone-sensitive prostate cancer. The application was withdrawn on 16 September. EMA describes uncertain clinical meaningfulness, insufficient overall-survival data, and more serious adverse effects and treatment discontinuations. The approved breast-cancer use remains; this is not a market recall.
Web publication / document: 2026-11-03 / 2026-10-16. EMA/227813/2026;EMA/VR/0000293735.
EMA — official source · Primary attachment 1 · Primary attachment 2
EMA: pharmacovigilance industry-platform highlights
EMA published highlights of its 20 October pharmacovigilance industry-platform meeting, addressing monthly ICSR compliance reports, EudraVigilance reconciliation, CMDh outcome transparency and AI under human accountability. Planned tools and guidance must be distinguished from requirements already in force.
Web publication / document: 2026-11-03 / 2026-10-30. EMA/236746/2026.
For QPPV, LQPPV and LCPPV professionals, these materials can support source review, local applicability assessment, controlled safety-information updates and risk-minimisation follow-up. Role definitions and duties differ between jurisdictions.