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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 3201–3220 of 39,430 recalls

Class IIOngoing

Philips X7-2t Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips X5-1 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Ongoing

Philips S8-3t Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips XL14-3 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips C5-1 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips L12-4 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

Encore Medical, LP

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

May 28, 2025 · DeviceView details →

Class IIOngoing

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Stryker GmbH

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips VL13-5 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips L8-4 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips L9-3 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

Philips S7-3t Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →

Class IIOngoing

KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493

Microbiologics Inc

Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

May 27, 2025 · DeviceView details →

Class IIOngoing

O-arm O2 Imaging System. Mobile X-Ray System.

Medtronic Navigation, Inc.-Boxborough

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

May 27, 2025 · DeviceView details →

Class IIOngoing

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

CORIN MEDICAL, LTD.

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

May 23, 2025 · DeviceView details →

Class IIOngoing

SIGNA Architect

GE Medical Systems, LLC

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

May 23, 2025 · DeviceView details →

Class IIOngoing

EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.

QUANTUM SURGICAL SAS

Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

May 23, 2025 · DeviceView details →

Class IIOngoing

SIGNA Architect AIR

GE Medical Systems, LLC

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

May 23, 2025 · DeviceView details →

Class IIOngoing

Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

Jewel Precision Sheet Metal & Machining Co, Inc.

The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.

May 23, 2025 · DeviceView details →

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