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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 2501–2520 of 39,430 recalls

Class IIOngoing

NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

Northeast Scientific Inc.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

August 29, 2025 · DeviceView details →
Class IIOngoing

Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

Getinge Disinfection Ab

Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

ImaCor Inc.

Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

August 29, 2025 · DeviceView details →
Class IIOngoing

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

Northeast Scientific Inc.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

Northeast Scientific Inc.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

August 29, 2025 · DeviceView details →
Class IIOngoing

NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

Northeast Scientific Inc.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

August 29, 2025 · DeviceView details →
Class IIOngoing

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

Northeast Scientific Inc.

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
Class IIOngoing

Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

Fresenius Medical Care Holdings, Inc.

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

August 29, 2025 · DeviceView details →
Class IIOngoing

DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.

ConvaTec, Inc

Wound dressing may have foreign matter on the product.

August 29, 2025 · DeviceView details →
Class IIOngoing

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519

Baxter Healthcare Corporation

IV sets may leak.

August 29, 2025 · DeviceView details →
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