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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 401–420 of 1,000 recalls

Class IIOngoing

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

March 2, 2026 · DeviceView details →
Class IIOngoing

SIGNA Premier systems

GE Healthcare LLC

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

February 27, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

Medline Industries, LP

Unapproved design changes to the products outside of the 510(k) clearance.

February 27, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953

Medline Industries, LP

Unapproved design changes to the products outside of the 510(k) clearance.

February 27, 2026 · DeviceView details →
Class IOngoing

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A.

Medline Industries, LP

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

February 27, 2026 · DeviceView details →
Class IOngoing

NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.

Medline Industries, LP

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

February 27, 2026 · DeviceView details →
Class IOngoing

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.

Medline Industries, LP

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

February 27, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

Medline Industries, LP

Unapproved design changes to the products outside of the 510(k) clearance.

February 27, 2026 · DeviceView details →
Class IOngoing

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B

Medline Industries, LP

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

February 27, 2026 · DeviceView details →
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