Medicine and device safety: 25 official communications for 4–5 November 2026
- 05-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
This review covers 25 newly posted or substantively updated official medicine, device and pharmacovigilance communications. Publication dates are distinguished from underlying action dates. New local communications about known issues and an initiated safety review are identified as such.
TGA: testing of Synedica peptide products
TGA found no detectable labelled TB-500 in tested BPC 157 & TB 500 10 mg, KLOW 80 mg and BARBIE KLOW 100 mg products. Tested Retatrutide 10 mg contained less retatrutide than labelled, with substantial variation between samples. TGA advises against using Synedica peptide products and recommends pharmacy disposal. The laboratory findings concern the specified tested products.
Web publication / underlying document or action: 2026-11-05 / 2026-11-05. No separate document number shown.
Plateletworks Collagen Kit: falsely low aggregation risk
Health Canada posted a Type II recall of lot 3-26 (3-26-552076), catalogue 5852. Affected tubes may produce falsely low collagen aggregation results suggesting abnormal platelet function. A kit that passes local quality control may still contain affected tubes. Questionable results should be repeated in duplicate and interpreted alongside clinical information.
Web publication / underlying document or action: 2026-11-04 / 2026-10-21. RA-82907.
Olympus: recall of specified previously loaned devices
Health Canada reports that certain devices intended for human use were incorrectly deployed for animal use. After return and reprocessing, the same devices were issued to hospitals for human clinical use. The Type II recall identifies models and serial numbers and is classified as a sterility issue. Healthcare facilities should contact the manufacturer for further information.
Web publication / underlying document or action: 2026-11-04 / 2026-10-14. RA-82906.
KayserBett IDA: injury risk when the hand control is not locked
Health Canada posted a Type II recall for IDA-1 and IDA-2 beds. Following a serious incident involving an OLAF model outside Canada, the manufacturer identified a comparable injury risk for the Canadian IDA model. The notice attributes the risk specifically to failure to follow the instructions for locking the hand control after use. Contact the manufacturer for affected serial numbers.
Web publication / underlying document or action: 2026-11-04 / 2026-04-30. RA-82903.
Azathioprine: newly listed review of potential PRES risk
Health Canada’s list updated on 4 November identifies a review initiated in September concerning azathioprine-containing products and potential posterior reversible encephalopathy syndrome (PRES). The trigger was a manufacturer notification of foreign action. Listing a review does not establish causality, and this entry does not provide a completed review conclusion.
Web publication / underlying document or action: 2026-11-04 / 2026-09. MedEffect initiated reviews September2026.
Easily-LAPCMP: filtered actions may disappear from day two
Hospices Civils de Lyon describes a risk of omitted administration, care or monitoring: with legacy filtering enabled and a RESIN action-type filter, relevant actions disappear from day two. For v8.1.x/v9.0.x, replace action types in filters with individual actions and check the unfiltered chart in the meantime. A v9.0.x patch, CS_TempetePlus v08.20.22, is available from HF3 CU14. Users of unsupported v8.0.x should migrate to a supported version.
Web publication / underlying document or action: 2026-11-04 / 2026-10-22. R2632431;261022-HCL-Avis de sécurité.
Raffin Medical: new Steriflush and care-set instructions
ANSM published Raffin Medical notices for Steriflush syringes and associated care sets following an INFARMED inspection. The letters report no related serious incidents or adverse events. Reconcile the listed references and lots, quarantine affected stock and follow the return procedure. A separate protocol permits use of a subassembly with the syringe removed when continuity of care cannot otherwise be maintained; four specified references are excluded. This is a new distributor communication about an existing action.
Web publication / underlying document or action: 2026-11-04 / 2026-10-19/2026-10-21. R2631424;FSN2026-02/FSCA2026-01;FSN2026-01v1.
B. Braun: Steriflush recall communication
B. Braun’s notice covers all unexpired lots of seven specified Steriflush NaCl 0.9% syringe references. The action follows a mandatory INFARMED decision after inspection rather than reported serious incidents or adverse events. Stop use, quarantine affected products, notify downstream recipients and arrange return under the letter’s procedure. This is a distinct new French distributor communication.
Web publication / underlying document or action: 2026-11-04 / 2026-10-21. R2631406;INFARMED095/CD/2026.
American Orthodontics: MR Unsafe labelling
The newly posted ANSM notice explains MR Unsafe labelling added to the listed metal orthodontic devices in 2024. MRI artefacts and/or heating may interrupt imaging and delay diagnosis or treatment; one adverse event is reported. Design and materials are unchanged. The letter permits continued distribution and clinical use of devices without the symbol and requires no stock action or acknowledgement.
Web publication / underlying document or action: 2026-11-04 / 2026-09-25. R2630573/R2631274;FSN_CAR40198_2026.
Roche: expanded creatinine-reagent recommendation
ANSM expanded its recommendation to CREP Gen.2 03263991190 and Crea PAP 05401470190 in addition to the two previously named references. Creatinine results may be overestimated, mainly in patients with monoclonal gammopathy. The updated document identifies starting lots potentially affected. Where an alternative exists, stop use and quarantine the identified lots; otherwise follow the specified confirmatory testing and clinical correlation advice.
Web publication / underlying document or action: 2026-11-04 / 2026-11-02. R2629329;DIV-RECO26/01.
ANSM — official source · Primary attachment 1 · Primary attachment 2
Respreeza: new EMA communication on vial integrity
EMA published a DHPC on missed or delayed doses and potential infection if Respreeza vial integrity is compromised. If closure components loosen or detach during reconstitution, do not administer the product; retain the vial and Mix2Vial for investigation. Thirteen closure defects were confirmed by 30 September, with no related adverse events identified. The benefit-risk balance remains favourable. This is a new EU communication about an existing issue.
Web publication / underlying document or action: 2026-11-04 / 2026-11-04. EMA DHPC dissemination04Nov2026.
Anvisa: e-Notivisa to accept medicine quality complaints
Anvisa announced that from 9 November e-Notivisa will accept technical complaints about medicines, including suspected quality defects and falsification. Patients, caregivers and professionals with a CPF and active GOV.BR account can report. If medicine use caused harm, the system directs the user to Vigimed. This is a reporting-channel update rather than a new product-specific safety signal.
Web publication / underlying document or action: 2026-11-04 / 2026-11-04. Anvisa announcement04Nov2026.
FreeStyle Libre 3: new app update
Abbott advises updating to a version beginning 3.6.10 to address the previously described vulnerability and signal loss after the earlier update. Exploitation could distort glucose readings or alarms and affect treatment. As of 20 October, Abbott knew of no unauthorised access or adverse events. Current sensors can remain in use.
Web publication / underlying document or action: 2026-11-04 / 2026-10-22. ADC FA1002-2026;MHRA41295467.
Impella AIC: purge cassette recognition failures
Abiomed plans purge-sensor component replacement for all AICs. For the specified alarms, reinsert the purge disc and switch to a backup controller if unresolved, following the instructions. Transition can temporarily reduce haemodynamic support. The manufacturer reports 37 therapy-delay complaints classified as serious injury and three deaths: underlying illness was considered more likely, but a contribution from exchange-related delay could not be excluded. Use may continue pending service under the notice.
Web publication / underlying document or action: 2026-11-04 / 2026-08-01. 2026-FSN-0000154/2026-FA-0000154;MHRA41281142.
BVI Mini-Blade/Lamellar Blade: UK notice publication
MHRA published BVI’s notice on the previously described ophthalmic-blade packaging seal issue. Loss of the sterile barrier increases infection risk. Reconcile lots, quarantine stock, stop use and distribution, and return as instructed. One complaint and no related adverse health outcomes are reported. The French communication about the same event was covered previously.
Web publication / underlying document or action: 2026-11-04 / 2026-11-02. FA-26-004;MHRA41324169;MHRA41324169.
Access HIV Ag/Ab Combo: reversed calibrator assignments
Beckman Coulter reports reversed calibrator assignments in the 2D barcodes of eight lots, potentially causing false reactive or nonreactive results. Stop the assay until calibrator lot 672285 or higher is available, discard calibrator kits as directed, and retrospectively assess the need for retesting. Additional instructions address blood-donor screening.
Web publication / underlying document or action: 2026-11-04 / 2026-10-23. FSN-26040;MHRA41298418.
Carestation 850/850c: reduced anaesthetic delivery
GE HealthCare describes reduced anaesthetic delivery with two vaporizers installed and the left one selected. If alarms go unnoticed, patient movement or intraoperative awareness may occur; no injuries are reported. Perform the specified checks and monitoring, follow the notice if the issue occurs, and arrange correction. The primary file does not provide a completed letter date.
Web publication / underlying document or action: 2026-11-04 / not stated in the primary file. GEHC34149;MHRA41271597.
ORBIS Medication: duplicated one-time prescription changes mode
Duplicating a prescription in “Unique” mode can silently reset it to “X times per day”, risking unintended repeated prescribing. Check the new line and restore the intended mode. The UK correction is planned for the first quarter of 2027; confirm availability and installation with the supplier.
Web publication / underlying document or action: 2026-11-04 / 2026-10-22. MST0125301;MHRA41256282.
MOSAIQ: risk of an unrecorded treatment fraction
Deleting the current calendar session during Harmony with the Hub delivery can prevent MOSAIQ from recording treatment without warning. This may lead to an extra fraction and excess prescribed dose. Do not change that session during delivery; reconcile records and follow Elekta’s Hub audit-log guidance if discrepancies arise.
Web publication / underlying document or action: 2026-11-04 / 2026-10. FCA-ESAB-0015;371-01-MSQ-023;MHRA41324088.
exoplan: library errors add 2 mm to drilling depth
exocad identifies two specific library configurations causing drilling 2 mm deeper than planned without warning, risking anatomical injury. Stop using affected libraries and install the corrected versions; cancel rather than continue past the blacklist warning. One near miss was detected before drilling; no patient harm is reported.
Web publication / underlying document or action: 2026-11-04 / 2026-10-26. FSN442582;revision2026-10-26;MHRA41321043.
6008 CAREsystem: ultrafiltration profile error
Changing UF time during an active profile can stop the pump, reducing ultrafiltration or dialysis dose. Fresenius recommends standard UF operation where clinically appropriate. If a profile is essential, follow the letter’s exact stop, time-adjustment and restart procedure. A corrective update remains under development.
Web publication / underlying document or action: 2026-11-04 / 2026-10-22. FMC FSN22Oct2026;MHRA41285628;MHRA41285628.
Easigown Comfort: surgical-gown batch recall
Full Support Healthcare recalls gown batch 692260406, product 38012A, after two observations of foreign matter in packaging. Contamination within an apparently intact sterile pouch cannot be excluded. Quarantine affected stock, prevent use, dispose under facility procedures and return the acknowledgement; replacements are provided without charge.
Web publication / underlying document or action: 2026-11-04 / 2026-10-23. FSN-2026-CMP7;MHRA41272969.
Keeler Slimline: inspection and replacement of ageing lithium batteries
Following a reported fire during charging, Keeler recommends checking the listed Slimline configurations. Root cause remains under investigation and no patient injury is reported. Remove damaged batteries and those in service over four years, with unknown history or unverified suitability; use only approved chargers.
Web publication / underlying document or action: 2026-11-04 / 2026-09-25. 2026/008/017/601/056;CAPA-000021;MHRA41325961.
Philips Azurion: potential loss of imaging
Power-supply failure during start or restart can make imaging unavailable on certain Azurion systems and delay urgent treatment. Philips reports no associated serious injuries. Use may continue under the notice; replacement is planned, with the redesigned assembly expected in the second quarter of 2028.
Web publication / underlying document or action: 2026-11-04 / 2026-10-15. 2025-IGT-BST-024;MHRA41274800.
Sysmex CN: falsely low results from probe deposits
Deposits on Sample Arm B can reduce sample volume and falsely lower the listed assay results. Sysmex reports seven complaints and no reported patient harm as of 15 October. Clean immediately as instructed, then at least weekly or every 16,000 tests, whichever comes first; document maintenance and assess whether retrospective review is indicated.
Web publication / underlying document or action: 2026-11-04 / 2026-10-15. FSCA2606;MHRA41272939.
For QPPV, LQPPV and LCPPV professionals, these materials support assessment of local relevance, safety-information updates, complaint and adverse-event routing, and risk-minimisation follow-up. Role definitions and duties differ between jurisdictions.