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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 4361–4380 of 39,430 recalls

Class IIOngoing

Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)

Medtronic Perfusion Systems

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

December 12, 2024 · DeviceView details →
Class ICompleted

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

Nuwellis Inc

The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

December 11, 2024 · Device
View details →
Class IIOngoing

MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

MICROVENTION INC.

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

December 11, 2024 · DeviceView details →
Class IIOngoing

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

HF Acquisition Co LLC

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

December 11, 2024 · DeviceView details →
Class IIOngoing

EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Encore Medical, LP

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

December 10, 2024 · DeviceView details →
Class IIOngoing

Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 150CM; 10) AB14W050150150, Size: 5MM X 150MM X 150CM; 11) AB14W050200090, Size: 5MM X 200MM X 90CM; 12) AB14W050200150, Size: 5MM X 200MM X 150CM; 13) AB14W060040090, Size: 6MM X 40MM X 90CM; 14) AB14W060040150, Size: 6MM X 40MM X 150CM; 15) AB14W060060150, Size: 6MM X 60MM X 150CM; 16) AB14W060080150, Size: 6MM X 80MM X 150CM; 17) AB14W060100150, Size: 6MM X 100MM X 150CM; 18) AB14W060120150, Size: 6MM X 120MM X 150CM; 19) AB14W060150150, Size: 6MM X 150MM X 150CM; 20) AB14W060200150, Size: 6MM X 200MM X 150CM; Balloon Dilatation Catheter

ev3 Inc

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

December 10, 2024 · DeviceView details →
Class IOngoing

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

Mercury Enterprises, Inc. dba Mercury Medical

Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

December 10, 2024 · DeviceView details →
Class IIOngoing

Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

Biocartis Nv

False-positive MSI-H results generated by the Idylla MSI Test.

December 10, 2024 · DeviceView details →
Class IOngoing

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD

Oxygen concentrator may melt or catch on fire during use.

December 9, 2024 · DeviceView details →
Class IOngoing

VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Maquet Cardiovascular, LLC

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

December 9, 2024 · DeviceView details →
Class IOngoing

Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Maquet Cardiovascular, LLC

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

December 9, 2024 · DeviceView details →
Class IOngoing

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi USA, LLC

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

December 6, 2024 · DeviceView details →
Class IIOngoing

Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB

GE Medical Systems, LLC

There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

December 6, 2024 · DeviceView details →
Class IIOngoing

Temporary Titanium Abutments

DDS Lab

Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.

December 6, 2024 · DeviceView details →
Class IIOngoing

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit. Component: No, not a component

QUIDEL ORTHO

Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

December 5, 2024 · DeviceView details →
Class IIOngoing

LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

Waldemar Link GmbH & Co. KG (Mfg Site)

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

December 5, 2024 · DeviceView details →
Class IIOngoing

Dialyzer Optiflux 160NRe

Fresenius Medical Care Holdings, Inc.

Potential for internal blood leaks due to cracked polyurethane

December 5, 2024 · DeviceView details →
Class IIOngoing

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit. Component: No, not a component

QUIDEL ORTHO

Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

December 5, 2024 · DeviceView details →
Class IIOngoing

Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.

Medtronic Navigation, Inc.

Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

December 4, 2024 · DeviceView details →
Class IIOngoing

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

Augustine Temperature Management, LLC

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

December 4, 2024 · DeviceView details →
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