Medicine and device safety updates | 11 November 2026
- 12-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
This edition brings together 42 official safety communications and updates from ten jurisdictions, reviewed on 11 November 2026. Topics include Eurneffy’s QTc warning, the Arrow PICC and Fucithalmic recalls, approved safety information changes in Ukraine, and continuity measures for Rifinah. It also includes Roszdravnadzor’s educational communication of 5 November. Each entry identifies the relevant regulator publication and the earlier document or action date where applicable.
Alendronate — warning on atypical fractures of other bones
NDDA published product-information changes following the PRAC/CMDh assessment of alendronate. The changes add a warning on atypical fractures of other bones, including the ulna and tibia, with long-term treatment, and list the reaction with frequency not known. Suspected atypical fracture calls for consideration of stopping bisphosphonate treatment pending an individual benefit–risk assessment.
Kazakhstan NDDA · PSUSA/00000078/202601 · Regulator publication 2026-11-10
Ukraine Ministry of Health Order No. 1768 — approved safety information changes
Appendix 3 to the Ukrainian Ministry of Health order of 10 November lists approved changes to registration materials. Safety changes include revisions to the contraindications, interactions and adverse reactions sections for Azithromycin-KR, the precautions and adverse reactions sections for Acnetrex (isotretinoin), and the adverse reactions section for Hipotel (telmisartan) following PRAC recommendations. The appendix identifies the sections revised. Refer to the approved information for each medicine for the exact wording.
Ukraine SEC · Приказ МОЗ Украины № 1768 / Ukraine Ministry of Health Order No. 1768 · Regulator publication 2026-11-10
Phenylephrine/tropicamide — updated warnings and adverse reactions
Ukraine’s State Expert Center reported PRAC recommendations to update combined ophthalmic product information. The update adds a warning on necrotising enterocolitis in premature infants and lists anaphylactic reaction and necrotising enterocolitis in premature infants with frequency not known. The two audience-specific cards represent one substantive communication.
Ukraine SEC · PSUSA/00010430/202511 · Regulator publication 2026-11-10
Surfacer — recall for detachment of the radiopaque tip
Health Canada published a Type I recall of the Surfacer system because the sheath’s radiopaque tip may detach. The notice reports four product complaints, two involving adverse events. The official source identifies the affected lots and catalogue number 600200/C.
Health Canada · RA-82937 · Regulator publication 2026-11-10 · Document or procedure 2026-11-03
Accell Connexus — recall of specific lots for potential particles
Health Canada published a Type II recall of specific Accell Connexus lots. Potential particulate contamination arises from contact between the ball spring and mixing container during manufacturing. The notice identifies lots 2067034-1 and 1037800-1.
Health Canada · RA-82936 · Regulator publication 2026-11-10 · Document or procedure 2026-10-27
Carestation 850 — risk of reduced anaesthetic concentration
Health Canada published a Type II recall concerning Carestation 850 and 850c anaesthesia systems, which can deliver a reduced concentration of anaesthetic agent. The notice directs users to the manufacturer for affected serial numbers. This Canadian communication concerns the same issue previously reported in the TGA action RC-2026-RN-00865-1.
Health Canada · RA-82934 · Regulator publication 2026-11-10 · Document or procedure 2026-10-28
Monaco — correction of static-arc plan exports
TGA lists a Class II product correction. An exported plan may omit the end angle for counterclockwise rotation, which a downstream system may interpret as a full rotation. The notice describes collision and dosimetric-error risks and provides Elekta’s user instructions.
TGA · RC-2026-RN-00914-1 · Action commencement 2026-11-09
Arrow PICC — recall for potential guidewire-coating detachment
TGA lists a Class I recall. Guidewire hydrophilic coating may swell unevenly and detach, releasing particles into the bloodstream and creating an embolic risk. As of 27 October, Teleflex had received 17 coating complaints, with no reported injury or death. Affected products must be stopped, quarantined and returned under the manufacturer’s instructions.
TGA · RC-2026-RN-00909-1 · Action commencement 2026-11-09
Philips Azurion — correction for potential loss of imaging
TGA lists a Class II correction. A power-supply failure at start or restart may leave the system unavailable for clinical use. Delayed urgent intervention may contribute to deterioration in a patient’s condition. The notice states that no serious injury potentially related to the problem has been reported.
TGA · RC-2026-RN-00899-1 · Action commencement 2026-11-09
Rituximab Riximyo — recall of a leaking infusion bag
TGA lists a Class II recall of compounded rituximab infusion batch BW261027144. A clinician identified a leak before administration, contained within the clear inner protective packaging, and the bag was discarded. The official notice confines the recall to this batch and states that other rituximab batches and Slade Health products are unaffected.
TGA · RC-2026-RN-00916-1; BW261027144 · Action commencement 2026-11-09
Salix — correction of MESA percentile calculation
TGA lists a Class II correction. Earlier Salix versions silently defaulted missing ethnicity to Caucasian for MESA percentile calculation, potentially misrepresenting coronary calcium burden relative to the reference population. Users are instructed to review affected historical studies. No associated adverse events, serious injuries or deaths have been reported.
TGA · RC-2026-RN-00911-1 · Action commencement 2026-11-09
Vercise — revised battery-estimation instructions
TGA lists a Class II correction updating the programming manual. IPG longevity and recharge estimates depend on impedance and provide supplementary information. An inaccurate estimate may delay replacement or recharging, with eventual depletion interrupting stimulation. Users should review the revised instructions.
TGA · RC-2026-RN-00910-1 · Action commencement 2026-11-09
Fucithalmic — recall of lot L49511
ANSM announced a precautionary recall of lot L49511, expiry 31 May 2029. Nonconforming aseptic-process simulation results mean microbiological contamination cannot be excluded. The laboratory reported no pharmacovigilance cases linked to this defect at the time of the notice. The recall covers pharmacies, healthcare establishments and distributors.
ANSM · L49511; CIP3400933191337 · Regulator publication 2026-11-10
Aerogen CNTS — incorrect syringe in specific packs
ANSM published a recall concerning ENFit enteral syringes incorrectly supplied in certain Aerogen CNTS packs. Their connector is incompatible with the continuous-nebulisation system and may delay treatment. The manufacturer’s letter identifies affected lots and instructions to inspect, set aside and replace incorrect syringes. No bodily injury was reported among the complaints reviewed.
ANSM · R2633375; CRN00HQZV · Regulator publication 2026-11-10 · Document or procedure 2026-10-30
V8 UltraCE — risk of mixed samples during IFE preparation
ANSM published a safety notice for V8 UltraCE. A rare combination of five conditions during IFE diluent replacement may mix two patients’ samples in one block and yield inaccurate results. Users should keep two diluent vials loaded, avoid using an affected tray and review historical data where the relevant practice occurred. A firmware update is planned.
ANSM · R2633181; CEP077 · Regulator publication 2026-11-10 · Document or procedure 2026-10-30
Rifinah — temporary substitution to maintain treatment
ANSM issued an exceptional temporary recommendation allowing unavailable Rifinah to be replaced with separate rifampicin and isoniazid products without a new prescription, subject to its conditions. Rifampicin 300 mg as Rifadine or Rimactan is combined with Rimifon 150 mg. The pharmacist records the replacement and dosage, informs the prescriber and counsels the patient to maintain tuberculosis treatment continuity.
ANSM · ANSM recommendation10Nov2026 · Regulator publication 2026-11-10
MFDS disseminated FDA information on potential NAION risk
MFDS disseminated a safety letter based on FDA’s 9 November communication on the potential increased risk of non-arteritic anterior ischaemic optic neuropathy with GLP-1 receptor agonists. This is a Korean communication referencing the FDA action covered previously. Its appendix lists 38 products from four companies and asks recipients to distribute and consider the information.
MFDS/KIDS · MFDS safety letter517 · Regulator publication 2026-11-10
Ebvallo — published risk-management-plan summary
Swissmedic listed the version 2.0 Ebvallo RMP summary dated 5 October. It describes identified risks of tumour flare reaction, graft-versus-host disease and cytokine release syndrome, with risk-minimisation and further-monitoring measures. The listing date is 10 November, while the filename contains 28 October. For use in Switzerland, the document refers to approved local product information.
Swissmedic · RMPv2.0, summaryv2.0 · Regulator publication 2026-11-10 · Document or procedure 2026-10-05
Meteospasmyl — circulation of lot VN9505 stopped
Roszdravnadzor stopped circulation of Meteospasmyl 60 mg + 300 mg capsules from lot VN9505 because of nonconforming labelling. The letter requires measures to remove threats to life and health and withdrawal controls. The notice concerns the specified batch within that lot and the regulator’s stated reason.
Roszdravnadzor · 01И-1295/26 · Regulator publication 2026-11-10
Apixaban Gedeon Richter — educational risk-minimisation materials
Roszdravnadzor published educational materials accompanying its 5 November letter for Apixaban Gedeon Richter, including a prescribing guide and patient alert card. They address bleeding prevention, risk assessment, correct use and patient counselling. The guide is version 2.0, prepared in August 2025.
Roszdravnadzor · 02И-1287/26 · Regulator publication 2026-11-05
Official source · Official attachment · Official attachment · Official attachment
Glivec — bone marrow oedema added as an adverse reaction
The procedural history updated on 10 November records bone marrow oedema in section 4.8 with frequency not known, based on post-marketing data and literature. The procedure opinion is dated 8 October. It also records a separate reduction in the recommended starting dose for dermatofibrosarcoma protuberans to 400 mg/day, with a decision dated 19 October.
EMA · EMA/VR/0000355998 · Regulator publication 2026-11-10 · Document or procedure 2026-10-08
Spinraza — clinical-information update from NURTURE and RESPOND
The procedural history updated on 10 November records revised sections 4.8, 5.1 and 5.2 based on NURTURE and RESPOND, including safety, efficacy and immunogenicity data. Annex II was revised and RMP version 14.1 submitted. The procedure opinion is dated 1 October.
EMA · EMA/VR/0000343403 · Regulator publication 2026-11-10 · Document or procedure 2026-10-01
Winlevi — revised product information and patient card
The procedural history first published on 10 November records revisions to sections 4.4 and 6.4 following linguistic review. It removes rebound-effect wording considered inappropriate for the professional audience, revises storage and patient-card wording, and corrects section 5.2 data. It describes the accepted product-information changes.
EMA · EMA/VR/0000380215 · Regulator publication 2026-11-10
Pemazyre — update following FIGHT-302
The procedural history updated on 10 November records changes to sections 4.4, 4.5 and 4.8 following final FIGHT-302 results, with Annex II and leaflet changes. A separate part of the grouped application submitted the final CIBI375A201 report. RMP version 4.2 was also submitted. The grouped procedure opinion is dated 15 October.
EMA · EMA/VR/0000343983 · Regulator publication 2026-11-10 · Document or procedure 2026-10-15
Eurneffy — warning on QTc prolongation and torsade de pointes
EMA records updated SmPC section 4.4 and leaflet section 2 implementing PRAC wording on increased risk of QTc prolongation and torsade de pointes following PSUSA/00011081/202602. The variation outcome and procedural-history update are dated 10 November.
EMA · EMA/VR/0000380714 · Regulator publication 2026-11-10
Imfinzi — updated instructions for subsequent infusions
The procedural history updated on 10 November describes revised administration instructions based on TOURMALINE. If the first infusion is well tolerated, subsequent infusions may be given over 30 minutes. Section 5.1 includes infusion-reaction data and the leaflet was revised. The procedure opinion is dated 24 September.
EMA · EMA/VR/0000361735 · Regulator publication 2026-11-10 · Document or procedure 2026-09-24
Andembry — revised adverse-event frequency information
The procedural history updated on 10 November records changes to sections 4.8 and 5.1 following final results of the open-label CSL312_3002 study of long-term garadacimab safety and efficacy in hereditary angioedema prophylaxis. Adverse-event frequencies, clinical pharmacology and efficacy information and the leaflet were revised. The procedure opinion is dated 8 October.
EMA · EMA/VR/0000348372 · Regulator publication 2026-11-10 · Document or procedure 2026-10-08
Herwenda — revised risk-management plan
EMA records an RMP update aligning Herwenda with reference product Herceptin. It removes the targeted follow-up questionnaire for the identified risk of oligohydramnios and moves medication-error follow-up from routine risk-minimisation measures to additional routine pharmacovigilance activities. Exposure, risk characterisation and 420 mg strength information are also updated. The variation outcome is dated 10 November.
EMA · EMA/VR/0000379682 · Regulator publication 2026-11-10
Impella AIC — implementation of earlier software corrections
In the letter published by MHRA, Abiomed reports that earlier corrections for screen freezing during purge-cassette change and false controller errors were not consistently applied to affected AICs. The problems can delay initiation or temporarily reduce haemodynamic support. Abiomed is arranging updates and permits hospital inventory to remain in use for continuity of care.
MHRA · 2026-FSN-0000160;2026-FA-0000160 · Regulator publication 2026-11-10 · Document or procedure 2026-10-20
Relay and TREO — recall for potential excessive endotoxin levels
MHRA published a letter recalling all unexpired RelayPlus, RelayPro and TREO systems for potential elevated endotoxin levels on delivery systems. The manufacturer describes risks including sepsis and death and requires users to stop, isolate and return affected products. The letter reports 26 complaints, four involving death. A causal relationship to this issue remains uncertain.
MHRA · FSN2026-003 · Regulator publication 2026-11-10
CODAN — warning on excessive flush rate
The letter published by MHRA describes a possible assembly fault in Xtrans and DPT-6000 pressure-monitoring sets with 3 mL/hour flushing, manufactured from 2 March to 31 August 2026. Excessive flushing can overdose the solution. Instructions for checking flow before use are reinforced. The manufacturer reports no patient harm.
MHRA · FSN_26-09-098;FSCA_26-09-098 · Regulator publication 2026-11-10 · Document or procedure 2026-10-27
Biosen — haemolysing-solution recall for leaking microtubes
MHRA published EKF’s notice on defective microtube lids for haemolysing solution. Leakage or evaporation can alter dilution and cause falsely elevated glucose and lactate results, unnecessary treatment or missed hypoglycaemia. Users must discontinue, quarantine and dispose of the specified lots.
MHRA · SI-260019FSN · Regulator publication 2026-11-10 · Document or procedure 2026-10-20
The Eye Doctor — notice concerning stolen lot A1127
MHRA published Finnsusp’s 24 July letter on theft of the entire shipment of The Eye Doctor Advanced Triple Action eye drops, lot A1127. Distribution outside controlled storage can compromise performance and create irritation or infection risks. The lot must not be used or distributed. The letter states there is no evidence it entered the authorised supply chain.
MHRA · LP007058 · Regulator publication 2026-11-10 · Document or procedure 2026-07-24
Hologic — risk of mammography C-arm freefall
MHRA published Hologic’s notice for 3Dimensions and Selenia Dimensions systems. Significant lift-nut wear may cause unexpected C-arm freefall and injury. Abnormal movement, noise or vibration requires stopping use and contacting service, alongside the specified inspections. This action concerns different systems and a different mechanism from the previously reviewed Horizon DXA notice.
MHRA · FA-00314;MISC-12191-EUR-2101Rev001 · Regulator publication 2026-11-10 · Document or procedure 2026-11-02
da Vinci SP — tip-cover recall for inadequate pouch sealing
Intuitive’s letter published by MHRA identifies da Vinci SP monopolar curved scissors tip cover 430035-13, lot K10260416. Inadequate outer-pouch sealing means sterility cannot be guaranteed, creating an infection risk. Affected products must be stopped, quarantined and returned. No complaints or serious incidents had been reported at the letter date.
MHRA · ISIFA2026-07-R;5556073-01RevA · Regulator publication 2026-11-10 · Document or procedure 2026-11-05
Rotaflow — check charging after battery operation
MHRA published Maquet’s notice on a software issue that can prevent charging from resuming after battery operation. Potential consequences include low blood flow, ischaemia and haemodynamic instability. Interim instructions include checking the indicator three minutes after reconnecting mains power and following the specified actions. A software correction is planned, with no related injuries or deaths reported.
MHRA · 1618466;DMS3467715V01 · Regulator publication 2026-11-10 · Document or procedure 2026-11-03
Poladus 150 — use may resume under the instructions
MHRA published Getinge’s updated notice allowing Poladus 150 H1/H2 use to resume. Repeated testing identified no safety risk requiring continued suspension when the instructions are followed. Compatibility and permitted processing must be verified for each device, while the facility validates its load and process. The letter provides no actual issue date.
MHRA · FSCA2026-015;OT1555113Rev03 · Regulator publication 2026-11-10
Myogenes Clozapine Test — clinical use discontinued
MHRA published a notice on insufficient evidence for the Myogenes Clozapine Test’s claimed clinical predictions. It instructs users to quarantine unused kits, stop using and sharing reports, and review patient management where indicated. The test is restricted to research use. This notice alone is not a basis to stop clozapine, alter doses or cease routine blood monitoring.
MHRA · MY-000197-CN;MY-000198-QR;KWQQU-FJTSM-FZNUM-REDKB · Regulator publication 2026-11-10 · Document or procedure 2026-11-04
Olympus Polyloop — replacement of the earlier device design
MHRA published Olympus’s 30 September letter replacing earlier Polyloop HX-400U-30 devices after reports that the loop could not release or detach. It describes a revised guide-pipe fixation design, replacement and return arrangements, and emergency-removal instructions. The manufacturer reports 170 serious injuries and no deaths.
MHRA · FY26-006-F-2 · Regulator publication 2026-11-10 · Document or procedure 2026-09-30
Lumify — new restriction on app downloads
In the November letter published by MHRA, Philips adds that the affected Lumify app has been removed from Google Play and the iOS store to prevent new downloads because of the registration issue. Installed apps remain operational and a software correction is being developed. Backup imaging and ready connectivity remain advised. This is a verified change from the September letter.
MHRA · 2026-PD-US-010 · Regulator publication 2026-11-10 · Document or procedure 2026-11
Siemens — revised barbiturate-assay specificity information
MHRA published three Siemens letters covering Atellica CH/CI, Dimension and Syva EMIT II Plus. They revise compound concentrations describing assay responses relative to secobarbital cutoffs. Users must use the corrected tables and determine appropriate action with the medical director, including review of previous results where applicable. The three platforms are grouped with their distinct letter identifiers.
MHRA · SYC27-01.C.OUS / SYC27-01.D.OUS / SYC27-01.A.OUS · Regulator publication 2026-11-10 · Document or procedure 2026-10
Official source · Official attachment · Official attachment · Official attachment
Evoke — corrective action for charging and stimulation failures
MHRA published Saluda’s letters concerning specific Evoke model 1042 stimulators. Board shorts may cause unintended stimulation during charging or prevent charging, potentially interrupting therapy and requiring replacement. Unimplanted affected devices must be quarantined. Implanted patients continue routine clinical management with individual evaluation of symptoms, and prophylactic replacement is not recommended.
MHRA · SAL-2026-001 / SAL-2026-001-UK;SAL-2026-001 · Regulator publication 2026-11-10 · Document or procedure 2026-10-20
For QPPV, LQPPV and LCPPV review where relevant to responsibilities in the applicable jurisdiction.
Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official material from MHRA, EMA, TGA, ANSM, Health Canada, Roszdravnadzor, Kazakhstan NDDA, Ukraine SEC, MFDS and Swissmedic, reviewed on 11 November 2026. Regulator publications and document dates are identified in each entry. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by a manufacturer or marketing authorisation holder or a quality concern affecting a company’s entire product portfolio. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.