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FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1161–1180 of 39,430 recalls

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 →

Class IIOngoing

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Maquet Cardiopulmonary Gmbh

Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.

January 9, 2026 · DeviceView details →

Class IIOngoing

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Medline Industries, LP

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

January 8, 2026 · DeviceView details →

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