FDA Medical Device Recalls

Early Alert: American Contract Systems Coronary Angio Pack Convenience Kits with Affected Namic RA Syringes

FDA's Center for Devices and Radiological Health (CDRH) issued an Early Alert for American Contract Systems Coronary Angio Pack convenience kits (ANCA80AQ, ANCA80AP) containing Namic Angiographic Control Syringes with Rotating Adaptor subject to Medline's recall. The syringes' rotating adaptor may unwind during use, causing loose connections or disconnection between syringe and manifold. This poses risks of biohazard exposure, blood loss, infection, air embolism, serious injury, or death. Four serious injuries have been reported as of March 13.

Early Alert: Medical Action Industries Halyard Kit Recall - Angiographic Syringe Risk

FDA issued an early alert regarding Medical Action Industries convenience kits containing Medline Namic RA syringes subject to a Class I recall. The syringe rotating adaptor on affected devices may unwind during use, resulting in loose connections or full disconnection, with potential for biohazard exposure, blood loss, infection, air embolism, serious injury, or death. As of March 13, four serious injuries have been reported with no deaths. Affected parties must identify, segregate, and quarantine affected product and apply warning labels.

Stryker Updates Use Instructions for Patient-Fitted TMJ Reconstruction Prostheses

Stryker issued an urgent medical device correction for TMJ Unilateral and Bilateral Implants (catalogs CHG010, CHG024, CHG031, CHG020, CHG026, CHG032). The FDA identified this as the most serious recall type due to screw hole positioning discrepancies that may cause recommended screw lengths to exceed bone thickness, risking cranial vault penetration. One serious injury has been reported. Healthcare providers should continue monitoring patients per follow-up protocols and contact Stryker if affected devices remain in unused inventory.

Correction for Philips Trilogy Evo Platform Ventilators - Non-Pneumatic Nebulizer Restrictions

FDA issued a Class I recall for Philips Trilogy Evo Platform ventilators (models DS2110X11B, DS2200X11B, DS2100X11B, DS2000X11B) due to risks from non-pneumatic nebulizer use causing tidal volume discrepancies and potential therapy under-delivery. Affected parties must update all devices to software version 1.05.15.00 and stop all use of non-pneumatic nebulizers. Failure to correct devices may result in serious injury or death.

Percussionaire Corp Issues Phasitron 5 In-Line Valve Correction, Updates Use Instructions

Percussionaire Corporation issued an Urgent Medical Device Correction for the Phasitron 5 In-Line Valve (P5-TEE) due to a design limitation where leaks can occur through the pressure relief valve even when fully closed. The FDA classified this as a Class I recall, the most serious type. Leakage poses a high risk of cardiopulmonary and neurological compromise in neonatal and infant patients due to unrecognized hypoventilation, potentially causing respiratory acidosis, hypoxemia, or respiratory failure. Four serious injuries have been reported as of September 3, 2025, with no deaths.

Draeger Atlan A350 and A350 XL Anesthesia Workstation Correction

FDA classified Draeger Atlan A350 and A350 XL anesthesia workstations as a Class I recall—the most serious type—due to potential piston ventilator failure before or during use. Draeger is instructing customers to inspect and, if necessary, replace the ventilator motor assembly. Healthcare providers may continue using affected devices under permanent supervision until the corrective action is implemented.

Merit Medical Recalls 16F Dual-Valved Splittable Sheath Introducer

Merit Medical is recalling the 16F Dual-Valved Splittable Sheath Introducer, a component used in several dialysis catheter kits, due to a design defect where the sheath introducer may not split as intended. The FDA has classified this as a Class I recall, the most serious type. Healthcare providers are advised to immediately stop using, apply recall stickers to, and destroy affected devices. Two serious injuries have been reported as of February 23, 2026, with no deaths associated with this issue.

AVID Medical Urgent Recall: Angiographic Syringes in Convenience Kits

FDA CDRH issued an Early Alert notifying the public that AVID Medical initiated an urgent medical device recall for convenience kits containing angiographic syringes affected by Medline's Namic RA Syringes recall. The recall involves 11 tray configurations with specific model numbers and UDI-DIs. Affected customers must identify, quarantine, and add warning labels to affected kits, with direction to remove and destroy Namic RA Syringes due to risk of serious injury or death.

Baxter Volara Single-Patient Use Circuits - Updated Instructions, Class I Recall

FDA announced a Class I recall correction for Baxter Volara single-patient use ventilator circuits after reports of oxygen desaturation and barotrauma risks. The affected Blue Ventilator Adaptor Module (Product Code M07937) may cause serious injury or death when used in-line with home care ventilators without following updated instructions. Baxter is notifying affected customers and providing clinical support including in-home training visits.

Medline Recalls Namic Angiographic Syringes Over Unwinding Risk

Medline Industries issued an urgent medical device recall for Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits after identifying that the syringe rotating adaptor may unwind during use, causing loose connections or full disconnection from the manifold. The FDA has classified this as the most serious recall type due to the risk of biohazard exposure, blood loss, infection, air embolism, serious injury, or death. Four serious injuries have been reported as of March 13.

Cook Medical Recalls Sizing Catheters Due to Marker Band Cracking Risk

FDA issued an early alert notifying healthcare providers that Cook Medical's Centimeter, Aurous Centimeter, and Beacon Tip Centimeter Sizing Catheters may have marker bands at increased risk of cracking or breakage. Potential adverse events include increased procedural time, device fragmentation, vessel injury, and life-threatening harm or death in worst-case scenarios. Healthcare providers should immediately stop using affected devices and return them to Cook Medical.

Abiomed Impella Heart Pump Purge Cassette Recall

The FDA issued a Class I recall notice for Abiomed's Generation 1 Impella Purge Cassettes and Impella RP Pump Sets due to an increased risk of purge leaks that may cause pump failure, resulting in patient death. Abiomed has reported four serious injuries and no deaths associated with this issue as of February 3, 2026. Healthcare facilities must immediately identify, quarantine, and return affected Generation 1 devices, transitioning to Generation 2 Purge Cassettes where available.

Heart Pump Device Correction - Impella RP SmartAssist Sensor Drift

FDA identified a Class I recall of Abiomed Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps due to differential pressure sensor drift causing inaccurate pump flow readings on the Automated Impella Controller. The correction involves updated Instructions for Use requiring clinicians to reference P-level flow rate tables instead of AIC display values. Affected product codes: 0046-0035 and 1000323.

Erbe USA Recalls Flexible Cryoprobes Due to Injury or Death Risk

Erbe USA is recalling flexible cryoprobes due to a risk of serious injury or death from device rupture during activation. The FDA has identified this as the most serious type of recall. Customers are instructed to discontinue use, remove, and quarantine affected devices.