Medicine and device safety updates | 10 November 2026
- 10-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
FDA’s class-wide GLP-1 labelling requirement, a vancomycin lot recall, and Health Canada’s review of myocarditis with entrectinib lead this edition. It also covers device notices and safety reporting guidance. For TGA and Medsafe database entries, the dates shown are action dates.
FDA requires a warning on potential NAION risk
FDA requires all application holders in the class to add a warning about the potential increased risk of non-arteritic anterior ischaemic optic neuropathy. In 126 trials, rates were 6.4 cases per 100,000 person-years with GLP-1 RAs and 3.8 with placebo or a non-GLP-1 RA glucose-lowering medicine. FDA advises prompt ophthalmology referral when NAION is suspected.
FDA · FDA Drug Safety Communication · Regulator publication 2026-11-09
Voluntary recall of one injectable vancomycin lot
FDA posted Eugia’s recall of lot 3VM26026A after a glass particle was found in a vial. The company identified a risk of serious vascular complications if administered and advised quarantining affected stock.
FDA · 3VM26026A; NDC 55150-471-01 · Regulator publication 2026-11-09 · Document or action 2026-11-06
Entrectinib and a possible risk of myocarditis
Health Canada identified a possible association with myocarditis and is working with the manufacturer to update the Canadian product monograph. The review included seven international cases involving hospitalisation, including one death. The catalogue dates the review to 6 November.
Health Canada · SSR1793369893405; DIN 02495007, 02495015 · Regulator publication 2026-11-06
Diphenhydramine: seven lots recalled over an impurity
Health Canada reported a Type II retail recall of four 25 mg and three 50 mg capsule lots over an out-of-specification impurity, N-nitroso-N-desmethyl diphenhydramine. The notice lists the affected lots.
Health Canada · RA-82928; DIN 00757683, 00757691 · Regulator publication 2026-11-09
Health Canada found bacteria in unauthorised injectable products
Health Canada reported bacterial contamination in tested samples of unauthorised injectable products sold online. The regulator warned of serious infection, hospitalisation and sepsis.
Health Canada · RA-82930 · Regulator publication 2026-11-06
Sysmex CN analysers: risk of falsely low results
Health Canada posted a Type II recall. Deposits on the sample probe may reduce the delivered sample volume and produce falsely low coagulation results.
Health Canada · RA-82927 · Regulator publication 2026-11-06 · Document or action 2026-10-29
Intersurgical: Canadian recall of specified breathing circuits
Health Canada posted a local Type II recall notice. Insufficient bonding can cause a soft connector to detach from the tube. Affected lots and models are listed in the notice.
Health Canada · RA-82926 · Regulator publication 2026-11-06 · Document or action 2026-10-28
Caspofungin and PAN membranes during continuous renal replacement therapy
Ukraine’s State Expert Center posted an agreed letter on the risk of reduced caspofungin efficacy with polyacrylonitrile membranes. It recommends considering an alternative membrane or antifungal according to clinical judgement.
Ukraine SEC · DHPC; РП UA/20924/01/01 · Regulator publication 2026-11-06 · Document or action 2026-11
Levofloxacin: encephalopathy to be added to product information
Ukraine’s State Expert Center published instructions for updating intravenous and oral product information. The change adds encephalopathy as an adverse reaction and updates neurological warnings. Two SEC cards describe one change.
Ukraine SEC · DE/H/5119/001-003/II/118 · Regulator publication 2026-11-06 · Document or action 2026-09-15/17
EMA consults on risk assessment in pregnancy and breastfeeding
The CHMP and PRAC draft covers the assessment of fertility, pregnancy and breastfeeding evidence and its translation into product information. Consultation runs from 9 November to 28 February 2027.
EMA · EMA/CHMP/PRAC/203927/2005 Rev.1 · Regulator publication 2026-11-09 · Document or action 2026-11-03
CDE guidance on safety reporting in clinical trials
CDE published technical guidance for investigators, sponsors and ethics committees on exchange of serious adverse event, SUSAR and other serious potential risk information, as well as development safety update reports. The notice took effect on publication.
NMPA/CDE · CDE Notice No. 52/2026 · Regulator publication 2026-11-09 · Document or action 2026-11-04
Respreeza: French letter names two lots
ANSM posted a letter about closure components loosening after reconstitution. It names two potentially affected French lots. A compromised closure can prevent administration and permit microbial contamination. This is a local follow-up to the earlier EMA communication.
ANSM · DHPC; P100897460, P100906885 · Regulator publication 2026-11-09 · Document or action 2026-11-04
DESIGN dental abutments: affected lots recalled
ANSM posted Deep Company’s recall for an out-of-tolerance bore diameter. The notice describes the risk of fatigue fracture and subsequent replacement.
ANSM · R2634045; 26-001 · Regulator publication 2026-11-09
TRACOE vario xl: carton may identify the wrong tube
ANSM posted a notice for lot 1100054512, REF 461-07. The carton may contain a different tracheostomy tube. The notice identifies the risk of selecting an unsuitable device and potential ventilation complications.
ANSM · R2633198; FSCA_20261015_TracoeVario · Regulator publication 2026-11-09 · Document or action 2026-10-30
exoplan: correction to surgical guide libraries
ANSM posted a notice about errors in two libraries that can produce excessive drilling depth in specific configurations. It identifies the affected components and corrective measures.
ANSM · R2631895; 442582 · Regulator publication 2026-11-09 · Document or action 2026-10-26
Aptiva CTD: paediatric sample testing restriction clarified
ANSM posted a notice replacing instructions revision 09 with revision 10. Evidence for applying adult thresholds to paediatric samples is insufficient. The manufacturer described the possibility of false positive and false negative results.
ANSM · R2630974; FA-2026-03 · Regulator publication 2026-11-09 · Document or action 2026-10-20
Aptiva CTD: expiry shortened for lot 100471
ANSM posted a separate notice for lot 100471. Its expiry was moved from 30 June to 30 January 2027 based on the available stability data. Use after the revised date could produce erroneous results.
ANSM · R2630939; FA-2026-04 · Regulator publication 2026-11-09 · Document or action 2026-10-20
ARTIS: motorised movement may become unavailable
ANSM posted Siemens’ notice about stand or table movement becoming unavailable until a restart. This may delay repositioning or access to the patient during an intervention.
ANSM · R2630280; AX049/26/S · Regulator publication 2026-11-09 · Document or action 2026-10-06
cobas c 703: replacement wash-unit tubing
ANSM posted Roche’s updated notice. Damaged tubing can allow wash solution into other cuvettes and affect results. Roche reported availability of replacement tubing and set out interim measures.
ANSM · R2534502; FSN-RDS-Corelab-2025-006 v2 · Regulator publication 2026-11-09 · Document or action 2026-10-30
myPTM: SynchroMed handset software update
ANSM posted a letter announcing version 2.0.3155 or later. Older software may delay confirmation of a command, including a bolus, even after the pump has started delivering it.
ANSM · R2506084; FA1460 · Regulator publication 2026-11-09 · Document or action 2026-10
Official source · Official attachment · Official attachment · Official attachment
Access HIV Ag/Ab: calibrator lots recalled
ANSM posted a notice about transposed calibration values in the barcode. This can produce incorrect reactive or non-reactive results. The letter describes replacement and retrospective review.
ANSM · R2632631; FA-26040 · Regulator publication 2026-11-06 · Document or action 2026-10-23
EASILY: some prescribing alerts may be omitted
ANSM posted a letter from Hospices Civils de Lyon. With a particular prescribing workflow, the pop-up may omit some calculated alerts. The notice sets out interim measures and fixes by version.
ANSM · R2632433; 261023-HCL · Regulator publication 2026-11-06 · Document or action 2026-10-23
StatStrip Ketone: French notice for specified lots
ANSM posted a local recall over increased quality-control failures. A failure may delay reporting results. This is a separate French action on a previously covered issue.
ANSM · R2631739; 02-26SS-GLO-FR · Regulator publication 2026-11-06 · Document or action 2026-10
TrakCare: allergy alerts may be missed
ANSM posted a notice about VIDAL API checks that may fail to display a known-allergy alert in some situations. It describes additional checks pending correction.
ANSM · R2631430; FSN-25.6FRXX · Regulator publication 2026-11-06 · Document or action 2026-10-28
Allura Xper: French notice on the FlexVision display
ANSM posted a notice about a blank or frozen display during procedures, with the potential for delayed or inappropriate treatment. This is the French notice for a previously documented issue.
ANSM · R2630094; 2026-IGT BST-002 · Regulator publication 2026-11-06 · Document or action 2026-10
JSHealth Vitamins Immune+ 60 tablets
TGA described continuing anaphylaxis reports with Andrographis products. All unexpired lots of this listed medicine are subject to a consumer-level Class I recall.
TGA · RC-2026-RN-00900-1 · Document or action 2026-11-06
Panocell-20. An in vitro diagnostic medical device (IVD).
The master list incorrectly identifies a donor cell as Jk(b) positive. An anti-Jkb test may therefore give a negative reaction with that cell.
TGA · RC-2026-RN-00902-1 · Document or action 2026-11-06
Cardiosave Intra-Aortic Balloon Pumps (IABP) with D.03 software Cardiosave Hybrid IABP
TGA described an autofill software failure that may prevent balloon pump support from starting or resuming.
TGA · RC-2026-RN-00827-1 · Document or action 2026-11-05
Carestation 850 and 850c Anesthesia Systems Carestation 850 Ref: 1012-9850-000 Carestation 850c Ref: 1012-9855-000 Field Replaceable Unit Selector Val
TGA described possible underdelivery of sevoflurane or isoflurane from the left vaporiser when two vaporisers are installed. Movement or intraoperative awareness may occur if alarms are missed.
TGA · RC-2026-RN-00865-1 · Document or action 2026-11-04
CN-3000 System and CN-6000 System. An in vitro diagnostic medical device (IVD). CN-3000 System Material Numbers: 11554200, 11694236 CN-6000 System Mat
Deposits on the sample probe can give falsely low coagulation results and affect anticoagulation decisions.
TGA · RC-2026-RN-00886-1 · Document or action 2026-11-04
Smoothbore Breathing Systems
An insufficient connector bond can result in separation, interrupted ventilation and oxygen desaturation.
TGA · RC-2026-RN-00890-1 · Document or action 2026-11-04
Vanta Clinician Programmer Application (CPA) and Vanta Implantable Neurostimulator (INS) Vanta Clinician Programmer Application Model: A71200 Vanta Im
TGA described a firmware update addressing a previously identified risk of neurostimulator damage following cardioversion.
TGA · RC-2026-RN-00888-1 · Document or action 2026-11-04
Cyclophosphamide 110mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
One compounded lot was labelled with the wrong drug and dose. The issue was detected before administration and the lot was quarantined and replaced.
TGA · RC-2026-RN-00887-1 · Document or action 2026-10-30
Infinity Ammonia Standard Set. An in vitro diagnostic medical device (IVD). Catalog Number: TR60901
TGA described ammonia calibration bias that may affect decisions on prognosis and treatment.
TGA · RC-2026-RN-00880-1 · Document or action 2026-10-30
OptiCross Intravascular Ultrasound (IVUS) Imaging Catheters OptiCross Coronary Imaging Catheter Material Numbers: H749518100, H749518120 Opticross HD
TGA described revised catheter flushing instructions after reports of air embolism, including fatalities. The notice sets out what to do if air is suspected.
TGA · RC-2026-RN-00858-1 · Document or action 2026-10-30
BVI – Beaver Mini-Blades
Medsafe posted a hospital recall over a compromised seal that could affect blade sterility.
Medsafe · Medsafe action 37859 · Document or action 2026-11-04
RIDA Setup 3.01.05
Medsafe reported a software error that can assign results to the wrong sample under specified conditions.
Medsafe · Medsafe action 37865 · Document or action 2026-11-04
Intelerad-InteleradPACS
Medsafe reported that a deletion rule may match unintended images, with potential diagnostic error, delay or repeat imaging.
Medsafe · Medsafe action 37834 · Document or action 2026-11-02
This edition is intended for QPPV, LQPPV and LCPPV review where relevant to local responsibilities.
Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications from FDA, Health Canada, ANSM, EMA, Ukraine’s State Expert Center, China’s CDE, TGA and Medsafe reviewed on 10 November 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturer or marketing authorisation holder or a quality concern affecting an entire product portfolio. Company and product names identify the official materials. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.