Medicine and device safety updates | 14 November 2026
- 14-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
This review covers 34 groups of official medicine and device safety communications across eight jurisdictions. FDA posted Medline's update on its recall of beds and accessories, TGA recorded two Class I consumer recalls concerning anaphylaxis, and Ukraine's State Expert Center published product-information recommendations. Each entry distinguishes the source-card date from the date of the original document or action.
For QPPV, LQPPV and LCPPV, relevance and follow-up depend on the applicable jurisdiction, product and local responsibilities.
Choline salicylate: warnings and PSUR monitoring
Ukraine SEC calls for updated oromucosal warnings on peptic ulcer disease, concomitant aspirin or other salicylates, and pregnancy. Existing stricter pregnancy recommendations must be retained. PSUR monitoring continues for hypersensitivity, Reye syndrome in children, pregnancy and breastfeeding. The communication was published on 12 November and reports the July PRAC assessment. The Ukrainian register snapshot of 9 November lists only Otinum ear drops. The warnings described here relate to oromucosal use.
Dimenhydrinate: severe skin reactions and misuse
Ukraine SEC recommends warnings on misuse, severe cutaneous reactions and Stevens–Johnson syndrome. Stevens–Johnson syndrome and fixed drug eruption are added with frequency unknown, with advice on additive anticholinergic effects. The next PSUR should include cumulative reviews of toxic epidermal necrolysis and misuse, and monitoring of paediatric overdose and medication errors. The Ukrainian register snapshot lists two single-ingredient dimenhydrinate 50 mg products and no caffeine combination.
Medline: updated bed repair and replacement programme
FDA posted an updated Medline recall announcement addressing fire and entrapment hazards. The company reported seven deaths and 35 serious injuries as of 8 November. The announcement sets out interim use instructions and repair, replacement or refund options, and advises against unauthorised repairs. This updates the recall initiated on 14 October.
OsteoDenx: recall for undeclared milk
FDA published bioQuad’s recall of two OsteoDenx lots for undeclared milk. The capsules contain lactoferrin derived from cow’s milk, creating a risk of serious or life-threatening reactions in people with milk allergy. No illnesses had been reported at the time of the announcement.
Candy Power For Man: undeclared tadalafil
The Eros Apothecary announcement posted by FDA recalls the product after detection of undeclared tadalafil. Interaction with nitrate medicines may cause a dangerous fall in blood pressure. The action concerns the identified product and batch.
10 Day Forecast: undeclared sildenafil and acetaminophen
FDA posted Game Changer Products’ recall of 10 Day Forecast capsules containing undeclared sildenafil and acetaminophen. The notice identifies nitrate interaction and inadvertent acetaminophen exposure risks. The affected-product details and instructions are provided in the primary source.
Enalapril/hydrochlorothiazide: carton strength typo
MHRA reports that four Star Pharmaceuticals batches show 12.mg instead of 12.5 mg on the front carton face. Other carton faces, blister foil and leaflet state the correct strength. Tablet quality is unaffected; MHRA considers the risk low and advises continued dispensing and prescribed use.
Medartis: cortical screw lot recall
The recall concerns lot 26486330 of M2-5240.19/1 screws with an oversized external thread diameter. The primary notice describes insertion-related risks and action for unused stock. It does not call for removal of implanted screws or contacting all implanted patients.
Hydragel ISO-PAL: lectin component recall
Sebia identified reduced stability of lectin lot 26115/01, potentially affecting alkaline phosphatase isoenzyme quantification before expiry. Affected lectin vials should be quarantined and destroyed for replacement; other kit components are unaffected. No impact on previously reported results had been identified at the time of the letter.
Infinity Ammonia: reagent recall
Fisher Diagnostics/Thermo Fisher reports approximately 6–15% low calibration bias associated with affected Infinity Ammonia calibrators. Falsely low results may delay necessary treatment, particularly in neonates, children and patients with acute liver failure. The letter calls for stopping use of listed material and consulting the laboratory medical director on reassessing previous results.
Rotaflow: battery charging interruption
Getinge/Maquet reports possible interruption of Rotaflow console battery charging, identified during internal validation of replacement batteries. The notice provides power-check and continuity precautions for extracorporeal support; the affected-device scope is specified in its annex.
Vercise: battery estimate guidance
Boston Scientific updates clinician-programmer instructions for estimates of IPG recharge intervals and non-rechargeable battery longevity. ANSM posted the 6 November letter on 12 November. The IFU correction should not be described as a recall of all implants.
Majorque: patient lift safety precautions
Identites reports risks of a sling loop slipping off an open hook, a patient fall, excessive lifting load and finger pinching. The maximum load is 150 kg including patient and sling. Continued use of Majorque 825012 requires strict adherence to the updated instructions; the device should not be used if those precautions cannot be followed.
Sysmex CN: falsely low measurement results
Deposits on sample-armB probes may cause falsely low results. Siemens distributed Sysmex’s instructions for the affectedCN systems. Laboratories should follow the complete notice, inform users and return acknowledgement.
Vanta: software mitigation for two known issues
Medtronic released Vanta clinician-programmer app 2.1.4148 to mitigate inability to interrogate the implant and failure after cardioversion. The firmware mitigation applies during clinician-tablet communication for specified devices on 07.05.00; devices made after July 2024 already use 07.08.00. This updates two previously communicated safety actions.
Official source · Primary document 1 · Primary document 2 · Primary document 3 · Primary document 4
Xpert Xpress: follow-up on error 5015
Cepheid’s follow-up addresses INVALID results with error 5015 in samples containing high SARS-CoV-2 concentrations, potentially delaying antiviral treatment or isolation. The letter targets users of earlier IFUs; IFU 302-7085 Rev.F was issued inFebruary 2026.
Vercise: Canadian IFU correction
Health Canada posted an IFU correction on recharge-interval and IPG battery-longevity estimates. The Canadian action is dated 4 November and the card 13 November; it is distinguished from the French communication.
Azurion: two software issues
Health Canada describes continuous rebooting and a frontal-stand longitudinal position error, which may prevent X-ray imaging or motorised movement. The card identifies system scope and temporary recovery conditions.
Secaris: possible foreign matter
The recall concerns Secaris nasal gel lot 26A35A, which may contain foreign matter. Health Canada identifies retail-level recall depth and advises consulting a healthcare provider before discontinuing use.
Unauthorised peptides: bacterial contamination
Health Canada found Sphingomonas aquatilis/melonis in an injectable peptide product seized from Sage & Summit WellnessCo. It warns of serious infection and sepsis and advises against buying or using the identified unauthorised products. This does not establish contamination across the company’s entire portfolio.
BVI Mini Blades: seal integrity issue
Health Canada reports a possible open-seal condition in specified Mini Blades, compromising guaranteed sterility. The condition is intermittent and does not affect every unit in the listed lots; the precise scope is in the official card and manufacturer notice.
Spectra Optia: potential treatment delay
The notice concerns Spectra Optia systems running software 12.1. The population at greatest risk may experience a treatment delay if the AIM system cannot be disabled. The card states original publication 13 November despite a 12 November Last updated field; recall commencement was 2 November.
Centricity Universal Viewer: data-access vulnerability
Health Canada posted a vulnerability notice concerning launch from third-party applications using an unencrypted URL method. Unauthorised access may expose or permit alteration of patient data. The card identifies affected versions and a vulnerability, rather than a confirmed data breach.
KemSu: refusal recommendation confirmed
After re-examination EMA confirmed its recommendation to refuse KemSu for acute paediatric pain. Added benefit over sufentanil alone and an improved safety profile were not established. Proposed misuse/diversion measures were considered acceptable, but other safety and effectiveness concerns remained unresolved. This is a recommendation on an application, rather than a recall of an authorised product.
Rixathon and Riximyo: adverse-reaction section alignment
The procedural records for both products confirm acceptance of a type IB variation on 12 November. Section 4.8 of their summaries of product characteristics aligns with reference product MabThera. The procedural records do not identify a specific new adverse reaction.
Official source · Primary document 1 · Primary document 2 · Primary document 3
Intrarosa: updated risk management plan
EMA published RMP version 2.0, signed on 4 August 2026, and a procedural record of variation acceptance on 12 November 2026. The plan reflects fulfilment of the previously assessed drug-utilisation study and the European Commission decision of 7 December 2023 removing additional monitoring. This documents implementation of earlier decisions, rather than a new monitoring-removal decision in 2026 or a new safety signal.
HPRA: October field safety notice summary
HPRA published its October field safety notice summary for the Irish market. This review covers notices addressing erroneous laboratory results, interruption of critical therapy, sterility and medifa 7000 operating-table battery fire risks. The underlying notices predate publication of the digest. Device-specific models, lots and user actions should be checked against the corresponding primary documents.
Official source · Primary document 1 · Primary document 2 · Primary document 3 · Primary document 4
Aerogen CNTS: incompatible syringes
Some specified CNTS packs contain an ENFit Enteral Syringe barrel incompatible with the CNTS connector. TGA instructs users to inspect each syringe, isolate incorrect units with their packaging, avoid using them and never force a connection. Correct CNTS syringes may be used.
AV/AT, LivoClear and Ly)mex: recall over anaphylaxis risk
TGA records a Class I consumer recall of all unexpired batches. Reports of anaphylaxis associated with Andrographis continued despite label warnings. Consumers should stop using the listed products and return them; suppliers should quarantine remaining stock. Listings for these three products were cancelled on 23 September 2026 and sales ceased on 21 September. This recall commenced on 11 November.
Cold & Flu Strike: recall of all unexpired batches
TGA records a Class I consumer recall of Andrographis-containing Cold & Flu Strike 14T, 30T and 60T following sustained reports of anaphylaxis. All unexpired batches are affected. Consumers should stop use and return the product; distributors should quarantine affected stock.
DxC 500 AU/500i: laboratory result conversion errors
With non-default reporting units and multiple tests or replicates under one Sample ID, the software may apply a conversion factor more than once, producing falsely elevated or decreased results. Users should review configuration as instructed in the customer letter and arrange the software correction, expected in Q4 2026.
BVI Mini-Blades and Lamellar Blades: sterile barrier issue
An open packaging seal in affected lots may compromise sterility and increase infection risk. TGA instructs customers to inspect stock, quarantine affected products and stop their use and distribution. The record describes one complaint about open seals and no reported adverse health outcomes related to the issue.
Brainlab Cranial EM: navigation registration in infants
With Universal Atlas 6.0 in neonates under 29 days and infants under two years, automatic anatomical landmark detection may prevent acceptable Surface Matching registration. An appropriate backup registration or navigation method must be available and registration accuracy verified; insufficient or unverified results must not be used. Customer contact for the software revision is planned from December 2026.
T2 ALPHA IMN: incorrectly labelled screw length
Lot K17FE5A, catalogue 23615057S, contains a 75 mm screw rather than the labelled 57.5 mm screw. The potential harm is prolonged surgery while obtaining a backup screw. TGA instructs customers to inspect stock, quarantine affected units and arrange return and replacement with Stryker.
Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications from FDA, MHRA, EMA, ANSM, HPRA, Health Canada, TGA and Ukraine’s State Expert Center, reviewed on 14 November 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by any manufacturer or marketing authorisation holder or a quality concern affecting a company's entire product portfolio. Names identify the products and organisations concerned. Decisions should be based on the linked primary sources, the regulator’s instructions and the approved product information.