Product Safety

Australia TGA Schedules UDI Information Session Ahead of 1 July 2026 Mandatory Deadline

Australia’s Therapeutic Goods Administration has confirmed that Unique Device Identification will be a legally mandatory requirement for high-risk and implantable medical devices from 1 July 2026, and is holding an online information session for clinical quality registries on 25 May 2026. Manufacturers, sponsors and registry operators should now finalise UDI implementation plans so that device data, systems and processes are ready in time to maintain compliance and support robust clinical outcome monitoring.

24 May 2026, 21:41tga.gov.auAustralia

Australia TGA Clarifies Import and Supply Rules for Cosmetic Injectables

Australia’s Therapeutic Goods Administration has issued a factsheet reminding health practitioners that only sponsors or their agents may import cosmetic injectable medicines and devices for commercial supply, and that parallel-imported or otherwise unapproved products are unlawful. The guidance signals heightened enforcement focus on cosmetic injector supply chains, so clinics and wholesalers should review sourcing, ARTG status and use of formal access pathways to avoid product loss, penalties and referral to professional regulators.

24 May 2026, 21:41tgacomms.health.gov.auAustralia

Australia TGA Issues Product Correction for Flixotide and Pavtide Accuhaler Batches

Australia’s medicines regulator has issued a product correction for defined batches of GSK’s Flixotide and Pavtide Accuhaler asthma inhalers after finding some devices may stop automatically reloading doses, risking short-term loss of symptom control. Marketing authorisation holders, distributors and healthcare providers should identify any affected stock, reinforce the TGA’s handling and communication guidance with prescribers and patients, and review post-market surveillance for similar device-performance issues across inhaler portfolios.

24 May 2026, 21:40tga.gov.auAustralia

US FDA Announces Recall of Birch Benders 12oz Sweet Potato Pancake & Waffle Mix for Undeclared Egg

In May 2026 the US FDA announced a limited voluntary recall of one lot of Birch Benders 12oz Sweet Potato Pancake & Waffle Mix in the United States due to undeclared egg allergen risk. Food manufacturers, retailers, and food-service operators should verify and remove the specified lot code, review allergen control and labelling processes, and be alert to similar undeclared-allergen recalls that can trigger rapid product removals and liability exposure.

24 May 2026, 21:40fda.govUnited States

Delaware SB 297 Advances to House Judiciary, Clarifying Consumer Fraud Act Scope

Delaware’s SB 297, which clarifies that the state Consumer Fraud Act covers unfair or deceptive conduct before, during, and after consumer transactions, has passed the Senate and advanced to the House Judiciary Committee in May 2026. If enacted, this would significantly broaden enforcement exposure for businesses in Delaware by extending consumer-fraud risk beyond advertising and point-of-sale interactions to ongoing customer communications, collections, and after-sales performance.

24 May 2026, 21:34legis.delaware.govUnited States

UK Government Launches Consultation On Age Checks And Safety Rules For Commercial Sunbeds

The UK government has launched a 12-week consultation on new laws requiring age verification, staff supervision and stronger health warnings for commercial sunbeds, with potential implementation from 2027. If adopted, these rules would tighten controls on sunbed operators, reduce underage exposure to carcinogenic UV radiation and support a more preventive National Cancer Plan approach to skin cancer.

24 May 2026, 21:31gov.ukUnited Kingdom

Chile Drafts Safety Certification Protocol for Portable Power Stations (PE Nº8/12:2026)

Chile has notified a draft SEC safety certification protocol for portable power stations up to 6 kW, defining mandatory testing, sampling and labelling requirements based on IEC 62368-1, with comments due by 17 July 2026. Manufacturers and importers of battery-based portable generators targeting the Chilean market should plan for SEC certification, adjust designs and documentation to meet the new protocol, and factor in testing timelines before the rules become mandatory.

24 May 2026, 21:27members.wto.orgChile

US House Health Subcommittee Forwards Destruction of Hazardous Imports Act (H.R. 2715) to Full Committee

In May 2026, the US House Energy and Commerce Health Subcommittee advanced H.R. 2715 (Destruction of Hazardous Imports Act), forwarding the bill as amended to the full committee. If enacted, this FD&C Act amendment would broaden FDA’s authority to destroy refused imported articles that pose significant public health concerns and criminalise attempts to move such goods back into commerce, raising enforcement and supply-chain risk for importers of non-compliant products.

24 May 2026, 21:26congress.govUnited States

German Bundestag Adopts Pharmacy Reform Law (Apothekenversorgung-Weiterentwicklungsgesetz)

In May 2026 the German Bundestag adopted the Apothekenversorgung-Weiterentwicklungsgesetz, a far-reaching pharmacy reform that strengthens community pharmacies, expands their clinical and preventive tasks, and introduces tightly framed pharmacist prescribing powers for certain chronic and acute conditions. Once promulgated, the law will materially change how medicines, vaccinations and diagnostics are delivered through German pharmacies, while piloting PTA-led operations in rural areas and preparing a new remuneration framework that pharmacy operators and healthcare suppliers need to factor into medium-term planning.

24 May 2026, 21:17bundestag.deGermany

Slovenian Consumer Association Finds Bisphenols and Other Contaminants in Kitchen Towels

In May 2026 the Slovenian Consumer Association published independent lab tests on 13 paper kitchen towel brands, finding bisphenols and microbiological contamination in some recycled-fibre products and deeming at least one towel unsuitable for direct food contact. These results highlight higher risk profiles for certain recycled paper kitchen towels and may prompt manufacturers and retailers to tighten control of recycled fibre streams and anticipate pressure for stricter limits on bisphenols and hygiene in paper-based food-contact materials.

24 May 2026, 21:14zps.siSlovenia

US FDA Issues Early Alert on Abiomed Automated Impella Heart Pump Controller Restart Risk

In May 2026, the US FDA issued an early alert on Abiomed’s Automated Impella Controller heart pump systems after discovering a software issue that can trigger brief controller restarts and loss of circulatory support for patients. Hospitals using these heart pumps must follow updated operating instructions, plan for backup support, and monitor for a software fix, as continued use carries a small but serious risk of injury or death.

24 May 2026, 21:11fda.govUnited States

US FDA: Hometown Food Company Recalls Birch Benders Sweet Potato Pancake Mix for Undeclared Egg Allergen

In May 2026, Hometown Food Company voluntarily recalled a single US lot of Birch Benders 12 oz Sweet Potato Pancake & Waffle Mix after discovering undeclared egg, triggering an FDA-listed nationwide allergen recall. Food manufacturers, brand owners and retailers should remove affected stock, verify allergen labelling and change-control procedures, and reinforce supplier oversight to minimise repeat allergen-related recalls and associated liability.

24 May 2026, 21:11fda.govUnited States

US FDA Announces Recall of Whole Foods Minestrone Soup for Undeclared Shrimp

Kettle Cuisine has initiated a recall of specific lots of Whole Foods Market Kitchen Minestrone Soup in the US after undeclared shrimp was found in certain 24 oz cups, with products distributed across multiple states and via national online channels. This strengthens the need for food manufacturers and retailers to maintain strict allergen controls and traceability, as single-SKU labelling or filling errors can trigger multi-state recalls and reputational risk even before illnesses occur.

24 May 2026, 21:11fda.govUnited States

US FDA Approves ERVEBO Labelling Supplement (20 April 2026)

In April 2026, the US FDA approved a labelling supplement for Merck’s ERVEBO Ebola vaccine, adding Phase 2 safety and immunogenicity data for HIV-infected adults and adolescents. Regulatory and commercial teams must rapidly finalise and submit updated electronic labelling and ensure promotional materials align to avoid compliance risk around ERVEBO’s use in these populations.

24 May 2026, 21:03fda.govUnited States

US FDA Approves BLA Supplement for VIMKUNYA Manufacturing Process and Labelling

US FDA has approved a biologics license supplement for Bavarian Nordic’s VIMKUNYA chikungunya vaccine, confirming optimised CHIKV VLP manufacturing processes and associated labelling changes in the US market. This creates near-term obligations for SPL labelling submissions and promotional materials oversight, so regulatory, quality and commercial teams should coordinate to ensure timely, compliant implementation.

24 May 2026, 21:03fda.govUnited States

US FDA Approves HEMGENIX Labelling Supplement (29 April 2026)

On 29 April 2026, FDA’s Center for Biologics Evaluation and Research approved a Biologics License Application supplement for HEMGENIX to update the US Prescribing Information based on new efficacy and safety data. CSL Behring must implement the revised labelling and submit final Structured Product Labelling content within 14 days, ensuring all promotional materials align with the updated information and regulatory requirements.

24 May 2026, 21:02fda.govUnited States

US FDA Clears Biowy Multi-Chamber Freezing Bag Set (510(k) BK261343)

FDA has cleared Biowy Corporation’s Biowy Multi-Chamber Freezing Bag Set (510(k) BK261343) as substantially equivalent to a predicate device, enabling U.S. marketing from April 2026. This expands options for hematopoietic progenitor cell freezing and storage while reinforcing that manufacturers must maintain robust quality systems, labelling, reporting and identification controls for this device.

24 May 2026, 21:02fda.govUnited States

European Parliament Debates One Europe, One Market Roadmap and EU Inc 28th Regime

On 20 May 2026, the European Parliament held a high-profile debate where the European Commission outlined its “One Europe, One Market” roadmap, including plans for an EU-wide “EU Inc” company form, an Industrial Accelerator Act and other measures to complete the single market. This signals a coming wave of far-reaching proposals on corporate structures, product-market rules and enforcement, so legal and compliance teams should expect deeper EU-level harmonisation and start monitoring how these initiatives could reshape obligations and market access across sectors.

24 May 2026, 20:57europarl.europa.euEuropean Union

US FDA Class I Recall Of React Health VOCSN V+Pro Ventilators

In May 2026, the US FDA announced a Class I recall of React Health’s VOCSN V+Pro ventilators because a manufacturing defect can cause undetected oxygen leaks, reducing delivered oxygen and increasing fire risk. This forces hospitals and device managers to remove affected units from service immediately, substitute non-affected ventilators, and tighten recall and equipment risk controls for life-support devices.

24 May 2026, 20:52fda.govUnited States

Delaware HB 439 Proposes Truth In E-Bike Marketing Rules For Electric Mopeds And Motorcycles

Delaware has introduced HB 439 (Truth in E-Bike Marketing Act) to tighten definitions and impose strict advertising and disclosure requirements on the sale and rental of electric mopeds and motorcycles. If enacted, dealers and online sellers would need to overhaul labelling, marketing and point-of-sale documentation for these vehicles while moped use would be further restricted on bike lanes and pathways, reducing liability and crash-risk ambiguity.

24 May 2026, 20:50legis.delaware.govUnited States