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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 3561–3580 of 39,430 recalls

Class IIOngoing

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

March 31, 2025 · DeviceView details →

Class IIOngoing

Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.

AVID Medical, Inc.

An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

March 31, 2025 · DeviceView details →

Class IIOngoing

Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Outflow Patient Line (P/N 902-00039P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).

Belmont Instrument LLC

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

March 31, 2025 · DeviceView details →

Class IIOngoing

Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).

Belmont Instrument LLC

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

March 31, 2025 · DeviceView details →

Class IIOngoing

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Micro-X Ltd.

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

March 28, 2025 · DeviceView details →

Class IIOngoing

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Micro-X Ltd.

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

March 28, 2025 · DeviceView details →

Class IIOngoing

Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

Stryker GmbH

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

March 28, 2025 · DeviceView details →

Class IIOngoing

Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

Stryker GmbH

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

March 28, 2025 · DeviceView details →

Class IIOngoing

GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

Galt Medical Corporation

Due to a potential open seal in the sterile barrier packaging.

March 27, 2025 · DeviceView details →

Class IIOngoing

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

IHB OPERATIONS B.V.

The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.

March 27, 2025 · DeviceView details →

Class IIOngoing

B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

Galt Medical Corporation

Due to a potential open seal in the sterile barrier packaging .

March 27, 2025 · DeviceView details →

Class IIOngoing

B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

Galt Medical Corporation

Due to a potential open seal in the sterile barrier packaging .

March 27, 2025 · DeviceView details →

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Bausch & Lomb Surgical, Inc.

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

March 27, 2025 · DeviceView details →

Class IIOngoing

Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

Galt Medical Corporation

Due to a potential open seal in the sterile barrier packaging.

March 27, 2025 · DeviceView details →

Class IIOngoing

Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

Galt Medical Corporation

Due to a potential open seal in the sterile barrier packaging.

March 27, 2025 · DeviceView details →

Class IIOngoing

Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

Galt Medical Corporation

Due to a potential open seal in the sterile barrier packaging.

March 27, 2025 · DeviceView details →

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

Bausch & Lomb Surgical, Inc.

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

March 27, 2025 · DeviceView details →

Class IIOngoing

GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.

Galt Medical Corporation

Due to a potential open seal in the sterile barrier packaging .

March 27, 2025 · DeviceView details →

Class IIOngoing

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Beckman Coulter, Inc.

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

March 27, 2025 · DeviceView details →

Class IIOngoing

The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.

Trimble Ab

An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser safety Class 2 classification.

March 26, 2025 · DeviceView details →

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