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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 621–640 of 1,000 recalls

Class IOngoing

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20/10; Catalog numbers: 722029

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10C; Catalog number: 722001

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20/20; Catalog numbers: 722038

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

Fresenius Kabi USA, LLC

Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

January 10, 2025 · DeviceView details →
Class IOngoing

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

Spectranetics Corporation

Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

January 10, 2025 · DeviceView details →
Class IOngoing

Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

MEDLINE INDUSTRIES, LP - Northfield

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

December 31, 2024 · DeviceView details →
Class IOngoing

Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6) ARTERIAL LINE INSERTION TRAY, Item Number ART475; 7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A; 8) ARTERIAL LINE TRAY, Item Number ART545A; 9) ARTERIAL LINE INSERTION KIT, Item Number ART775C; 10) ARTERIAL LINE TRAY, Item Number ART840; 11) ARTERIAL LINE KIT, Item Number ART890B

MEDLINE INDUSTRIES, LP - Northfield

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

December 31, 2024 · DeviceView details →
Class IOngoing

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

ROi CPS LLC

There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..

December 26, 2024 · DeviceView details →
Class IOngoing

VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients

Percussionaire Corporation

Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.

December 23, 2024 · DeviceView details →
Class IOngoing

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Baxter Healthcare Corporation

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

December 20, 2024 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.

December 20, 2024 · DeviceView details →
Class IOngoing

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Baxter Healthcare Corporation

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

December 20, 2024 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.

December 20, 2024 · DeviceView details →
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