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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 681–700 of 1,000 recalls

Class IIOngoing

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Medtronic Perfusion Systems

During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

January 13, 2026 · DeviceView details →
Class IIOngoing

Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

Laerdal Medical Corporation

units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.

January 13, 2026 · Device
View details →
Class IIOngoing

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A

Baxter Healthcare Corporation

Pumps were released without full testing being performed, including occlusion alarm testing.

January 13, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-8030/12;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-8521/15;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-0027/15;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-2835/12;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-2836/11;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Endo-Model Replacement Plateau; Item Number: 15-0027/16;

Waldemar Link GmbH & Co. KG (Mfg Site)

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

January 12, 2026 · DeviceView details →
Class IIOngoing

Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Medartis AG

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

January 9, 2026 · DeviceView details →
Class IIOngoing

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

FUJIFILM Healthcare Americas Corporation

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

January 9, 2026 · DeviceView details →
Class IIOngoing

Diowave Laser System, REF: Diowave 250W

Technological Medical Advancements LLC

Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.

January 9, 2026 · DeviceView details →
Class IIOngoing

Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Medartis AG

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

January 9, 2026 · DeviceView details →
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