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🚨 FDA Issues Critical Labeling Update for Olympus BronchoscopesOlympus has released new global safety labeling after rep...
11/13/2025

🚨 FDA Issues Critical Labeling Update for Olympus Bronchoscopes
Olympus has released new global safety labeling after reports of endobronchial combustion linked to laser therapy, APC, and cautery during bronchoscopy — including at least one fatal case.

Hospitals, ASCs, and pulmonary teams must now:
✔ Review affected bronchoscope models
✔ Update staff training
✔ Ensure all revised labeling is implemented across units
✔ Reassess energy-device use in high-oxygen environments

This update isn’t just procedural — it impacts patient safety, device workflows, and compliance across pulmonary and surgical services.

👉 Read the full analysis here: https://www.statsurgicalsupply.com/news/olympus-issues-voluntary-labeling-update-for-bronchoscopes-following-endobronchial-combustion-repors

Olympus Corporation has issued a voluntary global labeling update for several of its bronchoscopic devices following serious safety concerns, including reports

🚨 FDA Issues Warning Letter to Philips Over Quality System DeficienciesThe FDA has formally cited Philips for regulatory...
11/10/2025

🚨 FDA Issues Warning Letter to Philips Over Quality System Deficiencies
The FDA has formally cited Philips for regulatory noncompliance across three manufacturing sites in the U.S. and Europe, following major inspections revealing quality-system regulation (QSR) violations.

🏥 Why this matters:
➡️ Hospitals and surgical centers must review procurement and service contracts involving Philips imaging, monitoring, and surgical devices.
➡️ Biomedical and supply-chain teams should prepare for potential supply disruptions, service delays, or part shortages.
➡️ Vendor compliance now directly affects clinical continuity and operational safety.

📖 Read what your hospital should do next to stay ahead of vendor risk: https://www.statsurgicalsupply.com/news/fda-issues-warning-letter-to-philips-facilities-a-supply-chain-alert-for-surgical-and-imaging-procurement

October 28, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has issued a formal warning letter to Philips following inspections at three of

💊 FDA Approves Revumenib for NPM1-Mutated AMLThe FDA has officially approved revumenib (Revuforj®) for adults and childr...
11/04/2025

💊 FDA Approves Revumenib for NPM1-Mutated AML
The FDA has officially approved revumenib (Revuforj®) for adults and children (≥1 year) with relapsed or refractory AML carrying an NPM1 mutation.

🏥 Why it matters:
➡️ Expands menin-inhibitor therapy to a new AML subgroup
➡️ Triggers major planning for hospital pharmacies and oncology supply chains
➡️ Requires updated formulary, procurement, and reimbursement protocols

👉 Read how hospitals, oncology centers, and procurement teams can prepare: https://www.statsurgicalsupply.com/news/fda-grants-approval-to-revumenib-for-npm1-mutated-relapsed-refractory-aml-what-hospitals-and-supply-chains-must-prepare-for

FDA Grants Approval to Revumenib for NPM1-Mutated Relapsed/Refractory AML — What Hospitals and Supply Chains Must Prepare For October 24, 2025 — Washington, D.C

⚠️ FDA Recalls ICU Medical and Philips Devices — Operational Impact AlertThe FDA has announced two major Class II recall...
10/31/2025

⚠️ FDA Recalls ICU Medical and Philips Devices — Operational Impact Alert
The FDA has announced two major Class II recalls affecting:
🧪 ICU Medical’s ChemoLock Vial Spikes (20 mm) — risk of leaks and contamination during chemotherapy preparation.
🩻 Philips CT 5300 scanners — software malfunction that can cause image misregistration or system freezing.

These recalls affect oncology infusion and intraoperative imaging services nationwide.
Hospitals and surgical centers should audit inventories, isolate affected lots, and coordinate corrective actions with the manufacturers immediately.

👉 Full details and hospital action plan: https://www.statsurgicalsupply.com/news/fda-issues-recalls-for-icu-medical-and-philips-devices-critical-impact-on-surgical-and-Imaging-operations

October 27, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has posted multiple Class II medical device recalls affecting widely used surgic

⚙️ FDA Raises the Bar for Medical Device SafetyThe FDA is tightening expectations on biocompatibility and particulate co...
10/24/2025

⚙️ FDA Raises the Bar for Medical Device Safety
The FDA is tightening expectations on biocompatibility and particulate control for implantable and intravascular devices, following updates to ISO 10993-1 and increased scrutiny of particulate contamination.

💡 Why it matters:
➡️ Manufacturers must provide new, risk-based biocompatibility justifications.
➡️ Hospitals and procurement teams must verify supplier controls.
➡️ Particulate testing and traceability are now critical for regulatory readiness.

👉 Read the full breakdown and checklist for compliance: https://www.statsurgicalsupply.com/news/fda-tightens-biocompatibility-and-particulate-expectations-what-device-makers-and-hospitals-must-do-now

October 14, 2025 The U.S. Food and Drug Administration (FDA) is signaling a step-change in how it evaluates medical devices—particularly on biocompatibility (IS

⚠️ FDA Issues Safety Warning on RF Microneedling DevicesThe FDA has released a public safety communication after receivi...
10/23/2025

⚠️ FDA Issues Safety Warning on RF Microneedling Devices
The FDA has released a public safety communication after receiving multiple reports of serious injuries related to radiofrequency (RF) microneedling systems, including burns, scarring, and nerve damage.

While these devices are mainly used for aesthetic skin treatments, the warning highlights new implications for hospitals and surgical centers, where complications may require surgical repair.

👉 Read the full story and see the FDA’s recommendations for hospitals, procurement teams, and clinicians: https://www.statsurgicalsupply.com/news/fda-issues-safety-warning-on-rf-microneedling-devices-surgical-risk-signals-new-procurement-imperatives

FDA Issues Safety Warning on RF Microneedling Devices: Surgical Risk Signals New Procurement Imperatives October 15, 2025 The U.S. Food and Drug Administration

🔒 FDA Issues Cybersecurity Correction for Abiomed Impella ControllersThe FDA has released a Class I cybersecurity correc...
10/17/2025

🔒 FDA Issues Cybersecurity Correction for Abiomed Impella Controllers
The FDA has released a Class I cybersecurity correction notice for certain Abiomed Automated Impella Controllers, used in cardiac procedures, after identifying vulnerabilities that could allow unauthorized access or device disruption.

💡 No injuries or attacks have been reported, but hospitals must install the new software update and limit network access until patches are complete.

👉 Learn what this means for cardiac centers and patient safety: https://www.statsurgicalsupply.com/news/fda-issues-cybersecurity-correction-notice-for-abiomed-s-impella-controllers

October 10, 2025 The U.S. Food and Drug Administration (FDA) has issued a cybersecurity correction notice involving specific models of Abiomed’s Automated Impe

⚠️ Trividia Health Recalls TRUE METRIX® Glucose Meters Due to Display DefectTrividia Health has issued a voluntary recal...
10/16/2025

⚠️ Trividia Health Recalls TRUE METRIX® Glucose Meters Due to Display Defect
Trividia Health has issued a voluntary recall of TRUE METRIX® blood glucose meters from lot KD0746, after discovering LCD display defects that may cause partial or missing numbers — potentially affecting reading accuracy.

Why it matters:
➡️ Defective readings can delay treatment decisions for patients with diabetes.
➡️ 601 meters from this lot were distributed nationwide in September 2025.
➡️ No injuries have been reported so far, but users should verify their lot number immediately.

📞 Contact Trividia Health Customer Care at 1-888-835-2723 or visit www.trividiahealth.com/productnotice
to check your device.

👉 Read the full recall details here: https://www.statsurgicalsupply.com/news/trividia-issues-voluntary-recall-of-601-true-metrix-blood-glucose-meters-over-defective-display-risk

October 7, 2025 Trividia Health, Inc. has initiated a voluntary recall of a limited number of its TRUE METRIX® self-monitoring blood glucose meters after detect

🤖 FDA Seeks Public Feedback on AI-Enabled Medical DevicesThe FDA has launched a public consultation to shape how AI-powe...
10/09/2025

🤖 FDA Seeks Public Feedback on AI-Enabled Medical Devices
The FDA has launched a public consultation to shape how AI-powered medical devices — from surgical robots to diagnostic imaging tools — should be monitored and evaluated throughout their lifecycle.

Why it matters:
➡️ AI devices continue learning after approval — raising new safety and oversight challenges.
➡️ The FDA wants input from hospitals, clinicians, and manufacturers on real-world performance, bias, and transparency.
➡️ Deadline for public comments: December 1, 2025.

👉 Read the full story and see what this means for the future of digital health: https://www.statsurgicalsupply.com/news/fda-opens-public-consultation-on-measuring-ai-enabled-medical-device-performance

October 6, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has launched a formal public consultation to gather feedback on how artificial in

🧬 New Hope for Type 2 Diabetes Patients Unresponsive to GLP-1 TherapiesBiomea Fusion has unveiled promising mid-stage da...
10/08/2025

🧬 New Hope for Type 2 Diabetes Patients Unresponsive to GLP-1 Therapies
Biomea Fusion has unveiled promising mid-stage data for its experimental drug icovamenib (BMF-219) — showing meaningful HbA1c reductions and potential durability beyond active treatment.

Why it matters:
➡️ Could help patients who don’t respond to current GLP-1 therapies
➡️ Suggests partial restoration of beta-cell function
➡️ Points toward a new era of disease-modifying diabetes care

👉 Read the full analysis and expert insights: https://www.statsurgicalsupply.com/news/biomea-s-icovamenib-shows-early-promise-in-type-2-diabetes-experts-urge-caution-as-data-remains-preliminary

October 6, 2025 Biomea Fusion, a clinical-stage biotechnology company, has unveiled encouraging mid-stage data for its investigational compound icovamenib (BMF

⚠️ FDA Expands Medical Device Recall AlertsThe FDA has broadened its Medical Device Recall Communications Program to inc...
10/03/2025

⚠️ FDA Expands Medical Device Recall Alerts
The FDA has broadened its Medical Device Recall Communications Program to include all device categories — from surgical staplers and orthopedic implants to PPE and diagnostic tools.

Why this matters:
➡️ Hospitals must now track a wider range of recalls in real time
➡️ Supply chain and OR workflows could be disrupted if not updated
➡️ Manufacturers face stricter expectations for transparency and reporting

👉 Read the full story and see what hospitals, manufacturers, and clinical teams must do next: https://www.statsurgicalsupply.com/news/fda-expands-medical-device-recall-alert-system-to-cover-entire-industry-surgical-stakeholdes-advised-to-increase-vigilance

September 29, 2025 | Silver Spring, MD — The U.S. Food and Drug Administration (FDA) announced today a major regulatory shift that broadens its Medical Device R

🚨 Global Recall Alert – Olympus ViziShot 2 FLEX NeedlesOlympus has issued a worldwide recall of specific lots of its Viz...
10/02/2025

🚨 Global Recall Alert – Olympus ViziShot 2 FLEX Needles
Olympus has issued a worldwide recall of specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles after reports of component detachment, including one patient death.

Why this matters:
➡️ Used in lung cancer diagnostics & thoracic surgery
➡️ Detached parts may remain in the airway, invisible on X-ray
➡️ High-risk for pulmonary and surgical patients

👉 Read the full story, clinical risks, and hospital actions: https://www.statsurgicalsupply.com/news/olympus-global-recall-vizishot-2-flex-needles-patient-death-for-pulmanary-and-surgical-teams

OLYMPUS ISSUES GLOBAL RECALL OF VIZISHOT 2 FLEX NEEDLES AFTER PATIENT DEATH: CRITICAL ALERT FOR PULMONARY AND SURGICAL TEAMS September 29, 2025 | Washington, D.

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