Stat Surgical Supply, 100 S Ashley Drive, Tampa, FL (2025)

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

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

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

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

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

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

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

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.

09/25/2025

⚠️ FDA Issues Early Safety Alert
Certain Medline surgical kits may contain previously recalled Medtronic cardiac cannulas, creating a hidden risk in cardiac surgery supply chains.

Why it matters:
➡️ Recalled devices may re-enter hospitals via third-party kits
➡️ Risk of kinking or tissue damage during open-heart procedures
➡️ Over 40 complaints, including 3 serious injuries

https://www.statsurgicalsupply.com/news/fda-early-alert-medline-kits-recalled-medtronic-cardiac-cannulas

Potential Cross-Distribution Risk Raises Concerns in Cardiac Surgery Supply Chain The U.S. Food and Drug Administration (FDA) has issued an early safety alert d

09/24/2025

🚨 FDA Issues Class II Recall on Orthopedic Surgical Device
Hospitals across 9 states are being urged to remove the 14 mm Distraction Pin by Folsom Metal Products / Frontier Devices due to unvalidated shelf life labeling. While no injuries have been reported, the potential risk in critical orthopedic surgeries is significant.

https://www.statsurgicalsupply.com/news/fda-class-ii-recall-folsom-metal-products-orthopedic-device

Folsom Metal Products Faces Class II Recall Affecting Orthopedic Device Distribution Across 9 States The U.S. Food and Drug Administration (FDA) has issued a Cl

09/19/2025

⚠️ FDA Issues Urgent Recall on Life-Saving Heart Devices ⚠️

What happens when the very device meant to save lives may fail at the most critical moment?

The FDA has issued a Class I recall — the most serious kind — for Boston Scientific’s defibrillation leads after reports of 16 deaths and 386 serious injuries. The issue: rising shock impedance that could prevent the device from delivering life-saving shocks.

👉 Should patients rush to replace their devices? Or is monitoring enough?

https://www.statsurgicalsupply.com/news/fda-class-i-recall-boston-scientific-defibrillation-leads

September 15, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most serious type of safety notice, for a ser

09/18/2025

🚨 FDA Issues Correction on Popular Insulin Pump 🚨
Did you know that a small wiring defect in a life-saving device could put thousands of patients at risk?

The FDA has announced a Class II correction for Tandem Diabetes Care’s t:slim X2 insulin pumps, used by thousands of people managing diabetes. The issue? Defective speaker wiring that could silence alarms or disrupt insulin delivery.

👉 Find out what this means for patients, clinicians, and hospitals — and why this device is not being pulled from the market.

September 15, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has announced a Class II device correction for the t:slim X2 insulin pump, a w

Stat Surgical Supply

10/24/2025

10/23/2025

10/17/2025

10/16/2025

10/09/2025

10/08/2025

10/03/2025

10/02/2025

09/25/2025

09/24/2025

09/19/2025

09/18/2025

Address

Telephone

Website

Alerts

Contact The Practice

Shortcuts

Share

Category