Argatroban and PEDMARQSI recalls, EMA updates and device safety — 15 October 2026

This digest covers official FDA, TGA, EMA, HPRA, Health Canada and ANVISA communications reviewed as of 15 October 2026. It includes specific-lot recalls, medical-device corrections and updates to medicine information. A newly published document about an earlier decision is not automatically a new clinical safety signal.

Medicine recalls: FDA and TGA

Argatroban Injection 250 mg/2.5 mL, Par Health/Endo. On 14 October the FDA published the company’s 13 October announcement recalling 22 lots because of particulate matter. Intravenous exposure may cause embolic and other vascular complications, including life-threatening harm. The company had received no associated adverse-event reports. The notice instructs stopping use/distribution of affected lots and returning stock. Verify lots and expiry dates against the FDA notice.

Chuan Xin Lian Antiphlogistic Tablet. TGA action RC-2026-RN-00805-1 commenced 13 October: Class I consumer recall, ARTG 432432, batch B4C1 (all unexpired batches), expiry 30 May 2029. The reason is anaphylaxis risk associated with Andrographis. The action calls for stopping use and returning the product for a refund. Official TGA record.

PEDMARQSI 8 g/100 mL. TGA action RC-2026-RN-00806-1 also commenced 13 October: Class II hospital recall of batches 497863, 490176, 490184, 456336, 467504 supplied through the Special Access Scheme. Visible particles were detected in retained samples; additional bulk batches were included as a precaution. Potential effects include embolic, thrombotic or infusion-site reactions; no related adverse events had been identified. TGA instructs quarantine and destruction under hospital protocol. TGA record and full scope.

EMA: product information and risk management

The following documents were published/updated on 14 October; underlying procedure dates are distinguished below.

• Welireg (belzutifan) — procedure VR/0000349497 of 3 September updates sections 4.5, 4.9 and 5.2 on interactions, overdose and pharmacokinetics. Specified inhibitor combinations require monitoring for anaemia/hypoxia; poor-metaboliser status alone does not automatically require dose adjustment.
• mRESVIA — 3 September procedure and RMP 6.2 include 150 adult solid-organ transplant recipients. No unexpected safety findings were observed; a diminished immune response remains possible. Product information and the RMP missing-information classification were updated.
• Humira (adalimumab) — 14 October procedure/RMP 20.0 move the P11-282 ulcerative-colitis registry final-report deadline from Q4 2026 to Q2 2027. This is a pharmacovigilance activity change, not a new clinical signal.
• Tenofovir disoproxil Viatris — published RMP 7.0 aligns with the reference product; procedure 13 June. Designated safety concerns, targeted follow-up forms and Antiretroviral Pregnancy Registry participation as an additional activity were removed from the RMP. Routine pharmacovigilance and approved precautions remain.
• Poherdy (pertuzumab) — 29 September procedure aligns information with the reference product following final APHINITY results, including clinical safety and efficacy sections.
• Nemluvio (nemolizumab) — 3 September procedure adds ARCADIA/OLYMPIA long-term-extension interim data to sections 4.8 and 5.1. The document explicitly reports no significant new concerns.
• Denosumab Ascend — initial assessment dated 25 June was first published. Safety is consistent with the known denosumab profile, with no new or concerning issues identified. The osteonecrosis-of-the-jaw patient card belongs to initial risk-management measures.

Health Canada and ANVISA: medical devices

Health Canada published three Type II notices on 14 October: CareLink SmartSync — RA-82784 (recall 24 September; Bluetooth disconnections and unintended/incomplete programming), Philips Allura Xper — RA-82780 (recall 9 October; FlexVision blank/frozen display requiring a cold restart), and Tracoe Experc — RA-82782 (recall 24 September; very low incidence of silicone-sleeve tearing with possible obstruction or migration). Check model/lot scope and instructions in each official record and with the manufacturer.

ANVISA Alert 5359, TruSystem 7500 concerns a correction/customer communication under FA-2026-027, not a recall. Unexpected lowering may displace a patient. The 7 October letter reports three complaints without patient injuries. Continued use depends on clinical judgement; unusual noise/performance requires discontinuation and service contact.

HPRA: September device field safety notices

The HPRA September compilation was published on 14 October and brings together earlier manufacturer letters. The entries concern specific actions, not company-wide product quality. CareLink FA1583 overlaps the Canadian action; the two SOLTIVE letters describe one correction.

Device / action	Issue and action in the official letter
Centricity PACS / Enterprise Archive	Historical migration may misassociate images. Suspend new inbound DICOM migration and verify identifiers pending correction.
Bravo CF — FA1581	Specified models/lots 64553F–68912F: capsule attachment/detachment problems. Quarantine and return; reported injuries relate to the surveillance interval in the letter.
da Vinci — ISIFA2024-09-C	Updated reusable instrument grip-cable scope. Replace specified versions; the letter does not identify a new or increased risk.
Direxion / HI-FLO	Resistance during advancement/withdrawal may damage the catheter. Stop using and return specified lots.
DORMOSTRIP	Reduced seal strength in lot 125/06-26 may compromise sterility. Quarantine and return/dispose as instructed.
Dexcom G7 — FAS-SD-26-004	Versions below 2.12: specified settings may affect vibration/delay alerts. Update the app; no serious injuries were reported.
Carescape CSCS 3.0.x	A restart may interrupt monitoring. Maintain alternative observation until monitoring and audible alarms resume; follow corrective instructions.
Centricity High Acuity	Specified display/print workflows may omit medication data or orders. Verify original records and apply the documented interim workflows.
Carestation 850/850c	Incomplete startup plus AC loss may shut down ventilation/anaesthesia. Follow startup checks and backup instructions.
TRUE METRIX AIR / GO	The Irish notice requires immediate discontinuation and transition to alternative glucose testing. Products should not be returned.
SmartSync Micra — FA1582	Inaccurate displayed battery longevity; actual battery performance is unaffected. Software update required.
SmartSync Common — FA1583	Bluetooth disconnections may cause unintended/incomplete programming. Update compatible iPadOS; this is the same action as HC RA-82784.
Spike SIDAM 4038	A loose purple connector may leak cytotoxic solution. Test within unopened primary packaging and replace deficient boxes as instructed.
Automated Impella Controller	Component failure may delay support during controller exchange. Conditional use and phased replacement continue. Reported deaths are not established as device-caused.
Amplatzer Amulet	IFU update addresses pulmonary-artery perforation: anatomical assessment and procedural planning. Device return is not required.
Atellica CH HDL / TP2	Reagent carryover may distort HbA1c or direct bilirubin on specified systems. Apply special washes/test-definition updates and assess earlier results.
NDI Passive Sphere / biopsy kit	Coating variability may impair navigation accuracy. Quarantine and return unused products in the specified scope.
PALACOS / COPAL pro	Monomer leakage may cause local skin/eye irritation. Eye protection and updated instructions; not a general cement recall.
OmniaSecure 3930M	Quarantine/return specified nonimplanted leads. Already implanted leads remain under routine care without additional action from this notice.
NOxBOXi / NOxMixer	Internal oxygen leakage may interrupt NO in specified modes. Pre-use checks, immediately available backup and tubing replacement; remove devices that fail checks.
SOLTIVE — FY25-089-F-1	Replace specified fibres because of thermal-injury risk. Use the corrected scope; excluded new-material lots should not be returned.
SOLTIVE — corrected scope	Update to the same action, not a second independent signal. Manufacturing cutoffs and excluded lots were corrected.
Stryker UHMWPE — RA2026-4417798	Recall of specified unused components. Potential harm is considered unlikely; post-market data did not establish increased clinical risk.
NGPod	Stop remaining devices/sensors, quarantine and dispose. The company cannot accept returns; financial closure is not attributed to the incidents.
InstAlert / SureStep hCG	Low hCG may produce false-positive interpretation. Positive results are presumptive and require clinical/laboratory confirmation; IFU clarification.
Philips MR DTI	Enhanced MR DICOM export may contain incorrect diffusion directions. Use Classic DICOM pending software correction.
IntelliVue MX750/850	Specified network conditions may cause repeated reboots and monitoring loss. Alternative observation and version R.00.03 or later.
CitraLock 4% — FSCA2026/01	Stop using and return lots 2507149/2509001. Serious reactions concerned an earlier batch; no new patient reactions were reported after additional controls.
BiCOAG — FY26-059-F	Ceramic-tip detachment is possible. Immediately stop using, quarantine and return specified unexpired models.
IntelePACS portals	Specified versions with Chrome/Edge 152 may display a prior report alongside current images. Use an alternative browser or refresh each study pending correction.
Philips MR R5/R11	Custom 3D Vane protocols may abort scans. Use the standard protocol or matrix ≤480 and ≤167 slices pending correction.
Carevo	Incomplete locking plus external force may open side support. Checks/IFU apply to the stated production period; spring replacement only for the specified subset.
Dexcom G7 — FAS-SD-26-005	In iOS 2.12, noncritical alerts follow Silent/Focus settings. Update the app; distinct from FAS-SD-26-004.
EntericBio Viral Panels 1/2/3	Incomplete pouch seals may cause invalid results/retesting. Inspect and quarantine open pouches. With the IFU followed, incorrect results are not reported.

Professional use

This digest may assist pharmacovigilance professionals, including QPPV, LQPPV and LCPPV, in assessing the applicability of official actions to relevant products and territories. Role names and duties depend on jurisdiction. Product-specific decisions should follow the current official source and approved information.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by FDA, TGA, EMA, HPRA, Health Canada and ANVISA, with source links and dates above, and current as of 15 October 2026. It is not medical or legal advice, does not replace the official source, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the company’s entire product portfolio. Company and product names are used only to identify the official material accurately. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.