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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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9 recalls that day

Windstone Medical Packaging Custom Convenience Kits Pre Op Kits

The kits contain B Braun IV administration sets with potential for backflow of medication from secondary IV containers into primary IV containers.

Moderate risk, FDA, Device defect

Micro-X Rover Mobile X-Ray System

The Rover Mobile X-ray System may malfunction, causing the X-ray to be inoperable.

Moderate risk, FDA, Device defect

Oxoid Agglutinating Sera, Salmonella 9-0

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 may cross-react with 2-0 within 60 seconds, potentially causing misidentification of Salmonella serotypes.

Moderate risk, FDA, Quality testing problem

Foundation Medicine FoundationOne CDx Sequencing Agent

Sequencing Agent SEQ0067, component of FoundationOne CDx, may increase phasing, potentially causing false-positive BARD1 splice site indel artifact variants.

Moderate risk, FDA, Device defect

LSL Healthcare Central Line Dressing, Foley Urine Collection, IV Start and Wound Closure Kits

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Moderate risk, FDA, Sterility problem

Arrow International Catheters and Introducer Kits

Arrow International is recalling its Arrow because receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured.

Moderate risk, FDA, Device defect

Beckman Coulter Access Total T4 Calibrator

Access Total T4 Calibrator has a negative bias, causing false low results.

Moderate risk, FDA, Device defect

SurgiSmoke Solutions Flamingo Funnel

Certain lots of Flamingo Funnel were made with a drape that is not compatible with gamma sterilization.

Moderate risk, FDA, Manufacturing problem

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes

The OER-ELITE Endoscope Reprocessor Connecting Tubes may have lock levers that fail prematurely.

Moderate risk, FDA, Device defect

2 recalls that day

nanOss 3D Advanced Bone Graft Substitute

The bone graft substitutes were incorrectly labeled with a 5-year shelf life, but the approved shelf life is four years.

Moderate risk, FDA, Labeling error

Davol Avitene Ultrafoam Microfibrillar Collagen Hemostat

Avitene Ultrafoam Microfibrillar Collagen Hemostat may contain foreign matter, confirmed to be inspect fragments.

Moderate risk, FDA, Foreign object

8 recalls that day

Uvlizer Ultraviolet-C Germicidal Wands

A handheld ultraviolet-C germicidal wand can expose nearby persons to UVC radiation above recommended limits.

Moderate risk, FDA, Device defect

Uvlizer Handheld Ultraviolet-C Germicidal Wands

The handheld ultraviolet-C germicidal wand can expose nearby persons to ultraviolet-C radiation at levels above safety guidelines.

Moderate risk, FDA, Device defect

Medline Guidewires, Syringes and Kits

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Moderate risk, FDA, Device defect

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Medline Convenience Kits with polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

Olympus Thunderbeat II Shears w/Ultrasonic Mode

Olympus Thunderbeat II Shears w/Ultrasonic Mode may have a distal tip component that detaches during use.

Moderate risk, FDA, Device defect

Magellan Diagnostics LeadCare Blood Lead Test Kits

LeadCare blood lead test kits may show falsely elevated results when used with certain third-party collection devices.

Moderate risk, FDA, Device defect

Integra LifeSciences CUSA Clarity C7000 Console

The CUSA Clarity C7000 Console has a software issue that renders the touch screen unresponsive.

Moderate risk, FDA, Software defect

Angiodynamics AccuVu and Soft-Vu Angiographic Catheter

Soft-Vu and AccuVu Angiographic Catheters have a manufacturing defect that may prevent a guidewire from passing through the catheter hub.

Moderate risk, FDA, Manufacturing problem

6 recalls that day

Windstone Medical Packaging Custom Convenience Kits with Medline Namic Angiographic Control Syringes

Custom Convenience Kits containing Medline Namic Angiographic Control Syringes with Rotating Adapter can unwind during use, causing loose or full disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno Angiography Systems

ARTIS Pheno VE30A and VE40A may capture lighter and darker patient images, causing less accurate 3D reconstruction.

Moderate risk, FDA, Device defect

Medline CENTURION Circumcision Kit

The Centurion Circumcision Kit was distributed without the required sterilization process and is not sterile.

Moderate risk, FDA, Sterility problem

Gentuity HF-OCT Imaging System

The Gentuity HF-OCT Imaging System may repeat frames during pullback, affecting length measurements.

Moderate risk, FDA, Software defect

Philips Spectral CT on Rails

Philips Spectral CT on Rails has software issues that could cause the gantry to remain at the current scan position.

Moderate risk, FDA, Software defect

Cellex Photopheresis System CELLEX Photopheresis Kit

The Cellex Photopheresis Kit has increased difficulty installing the centrifuge bowl, which may dislodge and break, causing treatment delay and blood loss.

Moderate risk, FDA, Device defect

4 recalls that day

Cytal Wound and Burn Matrices

Cytal Wound and Burn Matrices have an increased rate of out-of-specification endotoxin results.

Moderate risk, FDA, Quality testing problem

React Health PHOENIX 5L Oxygen Concentrator

The device did not meet internal quality specifications.

Moderate risk, FDA, Quality testing problem

B. Braun Hemodialysis Bloodlines

B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line.

High risk, FDA, Device defect

Clariance Elegance Anterior Cervical Plates

The Elegance cervical plates have a burr on the finished product.

Moderate risk, FDA, Device defect

1 recall that day

Cook Instinct Plus Endoscopic Clipping Device

The Instinct Plus Endoscopic Clipping Device may malfunction.

Moderate risk, FDA, Device defect

5 recalls that day

Remel Yeastone Broth

Products may report incorrect AST results during quality control.

Moderate risk, FDA, Device defect

LinkBio CORE Workstation

The LinkBio CORE Workstation may display an incorrect planning date on the start case menu screen.

Moderate risk, FDA, Device defect

Philips AneurysmFlow

Philips AneurysmFlow software may not provide reliable prognostic information for aneurysm occlusion.

Moderate risk, FDA, Device defect

Arjo Tenor Mobile Passive Patient Lift

The Arjo Tenor mobile passive patient lift has an internal component that may not meet required mechanical strength.

Moderate risk, FDA, Device defect

Beta Bionics iLet Ace Pump Kit and Dosing Decision Software

The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and severe hypoglycemia.

Moderate risk, FDA, Device defect

1 recall that day

Stryker Sustainability Solution Color Cuff

The cuffs may detach from the bladder at the welding connection.

Moderate risk, FDA, Device defect

2 recalls that day

Brahms B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test

The B.R.A.H.M.S PlGF Plus Kryptor test may show out-of-range quality control values, which could lead to falsely elevated sFlt-1/PlGF ratio results.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan Neg Multidrug Resistant MIC 1 Panels

MicroScan Neg Multidrug Resistant MIC 1 has a manufacturing issue with in vitro multidrug resistant test.

Moderate risk, FDA, Manufacturing problem

3 recalls that day

Medline Namic Angiographic Control Syringes and Medical Convenience Kits

Medline NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may unwind during use, causing a loose or full disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno and Artis Icono Biplane Systems

ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.

Moderate risk, FDA, Device defect

Spacelabs Healthcare Multi-Parameter Command Module

The Multi-parameter Command Module has a circuit board issue that may cause inaccurate readings or delayed care.

Moderate risk, FDA, Device defect

2 recalls that day

Cook Medical Guide Wires, Catheter Sets and Trays

Cook Medical Guide Wires, Catheter Sets and Trays have expiration dates that exceed the true shelf life.

Moderate risk, FDA, Labeling error

Molded Products Luer Cap Sets

The See Luer Cap Set can have a threaded sleeve that is not engaged and becomes unattached.

Moderate risk, FDA, Device defect

3 recalls that day

XTANT Medical Xpress Pedicle Screw System

The Xpress Pedicle Screw System was mislabeled with an incorrect part number, identifying it as a shorter screw length than it physically is.

Moderate risk, FDA, Labeling error

Tornier HRS Max Tuberosity Bodies and Trial

Tornier HRS Max parts were incorrectly labeled and are incompatible with the HRS Max system.

Moderate risk, FDA, Labeling error

Beckman Coulter MicroScan Neg MIC 3J

MicroScan Neg MIC 3J has a manufacturing issue missing a drug in well 4/4 but containing double the amount of antibiotics.

Moderate risk, FDA, Manufacturing problem

6 recalls that day

GE Healthcare SIGNA Premier Systems

SIGNA Premier systems, whole-body MR scanners, may have ferrous fittings that could attract and cause injury.

Moderate risk, FDA, Device defect

Medtronic MiniMed and Paradigm Insulin Pumps

Over-delivery can cause severe hypoglycemia, altered mental status, seizure, coma, or death.

Moderate risk, FDA, Device defect

Burlington Medical Radiation Protection Apparel

Burlington Medical BAT Coverage may degrade over time, decreasing its lifespan.

Moderate risk, FDA, Device defect

Oxoid Microbact Identification Kits Listeria 12L Kit

The Microbact Listeria Kit may identify an incorrect organism because of ambiguous color reactions in its wells.

Moderate risk, FDA, Device defect