Medical Device News Update - March 2025

FDA approvals, warning letters and Class I recalls issued during March 2025

Monthly roundup of FDA approvals, warning letters and recalls issued in March 2025

Each month, Let’s Talk Risk! (LTR) provides a comprehensive summary of new device approvals or clearances, warning letters, and Class I recall announcements issued by the FDA in the previous month.

As a risk practitioner, it is very important to stay up to date with the latest regulatory developments affecting the medical device industry. A review of latest innovations approved or cleared by the FDA helps in understanding different ways the agency evaluates benefit-risk of medical devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful in building awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Only publicly available information is curated in this article. Links to relevant sources are provided in the footnotes.

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Quick Summary

New device approvals/clearances

1. An automated endoscope channel cleaning device (DEN240018).

2. An in-vitro diagnostic test for detection of sexually transmitted diseases (DEN240020).

3. A total of 246 devices were cleared through the 510(k) pathway during March 2025. Days to FDA decision ranged from 3 to 574 days with a median of 115 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Neurology (NE) and Gastroenterology & Urology (GU), accounting for 63% (156/246) of devices cleared.

FDA warning letters

FDA issued two warning letters to medical device manufacturers in March 2025.

1. EpiCare Acquisitions, LLC: Quality system violations - design validation, complaints handling, adverse events reporting, CAPA, device history records, device master records, personnel training.

2. Dexcom, Inc.: Quality system violations - process validation, design input, design changes, design output, design validation, CAPA.

Class I recall announcements and early alerts

1. Getinge: risk of degradation inside a vaporizer used for general anesthesia (Removal).

2. Philips: risk of additional intervention due to challenges during implantation of the Tack Endovascular System (Removal and product discontinuation).

3. Baxter: risk of patient injury due to incorrect assembly of some solutions sets used in infusion pumps (Removal).

4. Fresenius Kabi USA: risk of under or over-dosing, or delay in therapy due to software issues in an infusion pump system (Correction).

5. Medtronic: risk of incomplete wall attachment and braid deformation in an embolization device used to treat brain aneurysms (Removal and Correction).

6. Smiths Medical: risk of port detachment used for venous access for repeated blood draws (Removal).

7. Bard Peripheral Vascular (BD): risk of vessel damage due to fracture of a rotating helix in an atherectomy device (Correction).

8. Baxter: risk of inadequate or delayed therapy due to missing motor mounting screws in infusion pumps (Removal).

9. Calyxo: risk of excessive kidney pressure in patients during aspiration (Early Alert).

10. BD: risk of incorrect or inadequate infusion from Alaris system due to system and software issues (Correction).

11. Smiths Medical: risk of inadequate ventilation due to smaller than expected diameter of endotracheal tubes (Removal).

12. Medtronic: risk of loose material in the male luer used in an aortic root cannula (Recall).

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