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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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14 recalls that day

bioMérieux VITEK 2 AST-N461 Test Kit

The Vitek 2 AST-N461 test kit may give false resistant results due to card pouch damage, potentially leading to less effective antibiotic treatments.

Moderate risk, FDA, Device defect

Medline Convenience Kits Containing Healthmark Instrument Channel Brushes

Medline convenience kits containing Healthmark Instrument Channel Brushes may have a sharp edge that can cause cut injury and infection.

Moderate risk, FDA, Device defect

Philips EPIQ Elite Diagnostic Ultrasound System

The Philips EPIQ Elite Diagnostic Ultrasound System has a software issue that can cause inaccurate blood flow velocity measurements and misdiagnosis.

Moderate risk, FDA, Software defect

Fresenius Medical Care CombiSet Hemodialysis Blood Tubing Sets

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Moderate risk, FDA, Device defect

Maquet PowerLED 300 Concealed Lighting System

The PowerLED 300 Concealed Lighting System can detach at the junction between the spring arm and suspension arm and fall, causing potential injury.

Moderate risk, FDA, Device defect

SeaSpine Mariner Deformity Extended Polyaxial Head

The proximal thread depth of the spinal device is out of design specification.

Moderate risk, FDA, Device defect

HomeFill Oxygen Cylinders

HomeFill Oxygen Cylinders do not carry the required medical gas labeling.

Moderate risk, FDA, Labeling error

CooperSurgical INCA Infant Nasal CPAP Sets

CooperSurgical INCA Infant Nasal CPAP Sets may exhibit a loose connection between the flexible tubing and the nasal cannula during assembly or use.

High risk, FDA, Device defect

Midmark IQvitals Zone

The Midmark IQvitals Zone may give inaccurate blood pressure readings when using the Linear Deflation Method.

Moderate risk, FDA, Device defect

Olympus EZDilate Endoscopic Balloon Dilators

The inflation chart label on the shaft of the EZDilate Endoscopic Balloon Dilator may show an incorrect balloon diameter.

Moderate risk, FDA, Labeling error

Olympus BiCOAG Hemostasis Probe

The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.

Moderate risk, FDA, Device defect

Heidelberg Engineering SPECTRALIS with Flex Module

The Spectralis with Flex Module may have wheels that come loose, causing the stand to tip over and possibly cause impact or crushing injuries.

Moderate risk, FDA, Device defect

3 recalls that day

Pi-Cardia ShortCut Device

The ShortCut transfemoral catheter has a weld issue that may cause the positioning arm to detach.

Moderate risk, FDA, Device defect

CADD Yellow Medication Cassette Reservoir with NRFit Connector

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing.

Moderate risk, FDA, Device defect

F & A Foundation Reign Medical Clench Staple System (Compression)

The Reign Medical Clench Staple System (Compression) has not had its performance characteristics adequately established.

Moderate risk, FDA, Device defect

12 recalls that day

Halyard Medical Trays

Halyard Medical Trays may have quality and sterility issues.

High risk, FDA, Sterility problem

Captus 4000e Thyroid Uptake System

The Captus 4000e Thyroid Uptake System has a potential failure of the tension bolt, allowing the spring arm to fall unexpectedly.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The purge flag component of the purge pressure sensor assembly can fail, leading to purge cassette recognition issues.

High risk, FDA, Device defect

Medline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery

Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.

Moderate risk, FDA, Sterility problem

Datex-Ohmeda Aisys Anesthesia Systems

Anesthesia systems can automatically transition to Alternate O2 control, interrupting anesthetic agent delivery and requiring clinician intervention.

Moderate risk, FDA, Device defect

Stryker Sustainability Solutions Ethicon XCEL Bladeless Trocars

Reusable access port system may crack or seperate during use.

Moderate risk, FDA, Device defect

Boston Scientific StoneSmart Connect Console

The StoneSmart Connect Console has a power adapter with a grounding path issue that may fail safety testing.

Moderate risk, FDA, Device defect

Medical Action Blood Culture Collection Kits

Medical Action Blood Culture Collection Kits contain applicators with an open or incomplete seal that may compromise sterility and lead to infection.

Moderate risk, FDA, Sterility problem

Howmedica Osteonics Orthopaedic Implant Components

Orthopaedic implant components made with aged polyethylene may wear excessively.

Moderate risk, FDA, Device defect

restor3d Kinos Axiom Total Ankle System with Axiom PSR, Flat-Cut (Cut Guide)

The Kinos Axiom Total Ankle System was packaged with incorrect cutting guides, which may cause delayed surgery, poor alignment, or implant loosening.

Moderate risk, FDA, Device defect

Hemospray Endoscopic Hemostat

Hemospray Endoscopic Hemostat has an issue with endoscope adherence and inability to spray powder.

Moderate risk, FDA, Device defect

Embecta Nano Pro Un-Cannulated Demo Samples

Pen needles labeled 'For Investigational Use Only' were distributed as commercially marketed devices.

Moderate risk, FDA, Labeling error

7 recalls that day

VERIQA RT MonteCarlo 3D v3 Software

When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly.

Moderate risk, FDA, Software defect

Straumann GM Helix Implant

The GM Helix Implant has a discrepancy between its packaging identification and the dimensions of the implant inside.

Moderate risk, FDA, Device defect

SunMed Tracheal Tube

The SunMed Tracheal Tube, Size 2.5, may not allow a suction catheter to pass through smoothly.

Moderate risk, FDA, Device defect

GE Healthcare Centricity Enterprise Archive, Enterprise Archive, Centricity PACS, Centricity PACS Server, Workflow Core Services, and Core Services Hub Software

GE Healthcare products may associate imaging data with the wrong patient, potentially leading to misdiagnosis or delayed care.

Moderate risk, FDA, Device defect

NOxBOXi Nitric Oxide Delivery System

The NOxBOXi Nitric Oxide Delivery System may leak oxygen tubing, potentially causing oxygen desaturation.

Moderate risk, FDA, Device defect

Happiest Baby SNOO Sleep Sacks

Extra small and extra large SNOO Sleep Sacks have not been reviewed for safety and effectiveness by the FDA.

Moderate risk, FDA, Device defect

BD Alaris Pump Infusion Sets

BD Alaris Pump Infusion Sets have discrepancies in performance data that may lead to inappropriate pump performance.

High risk, FDA, Device defect

3 recalls that day

Halyard IV Start Kits

The Halyard IV Start Kit contains applicators contaminated with Aspergillus penicillioides.

High risk, FDA, Contamination

Medline Convenience Kits

Medline Convenience Kits contain sterile applicators that may have fungal contamination, which can lead to serious infection or death.

High risk, FDA, Contamination

Nuclein DASH Rapid PCR Instrument

The DASH Rapid PCR Instrument has a software issue.

Moderate risk, FDA, Software defect

9 recalls that day

Bayer Medical Care MEDRAD Stellant FLEX Syringe Kit

The syringe kit may not have been properly sterilized due to a manufacturing sterilization issue.

Moderate risk, FDA, Device defect

Maquet Cardiopulmonary Percutaneous Insertion Kits and Guidewires

The Percutaneous Insertion Kit may not maintain sterile barrier integrity.

Moderate risk, FDA, Sterility problem

Carescape Central Station

Carescape Central Station may not resume patient monitoring for at least 3 minutes after restart, delaying recognition of clinical events.

Moderate risk, FDA, Device defect

Bravo CF Capsule Delivery Device

The Bravo CF capsule delivery device may fail to attach the capsule, risking aspiration, perforation, and bleeding.

High risk, FDA, Device defect

Medline Open Heart A Pack Convenience Kit

The Medline Convenience Kit contains a cannula that may have a sterile barrier breach, risking infection or other complications.

Moderate risk, FDA, Sterility problem

Philips Patient Information Center iX and Philips PIC iX Essentials

Philips Patient Information Center iX and Philips PIC iX Essentials may freeze and become unresponsive due to software malfunction.

Moderate risk, FDA, Software defect

StatStrip Glucose Meters

A software issue can cause the meter to retain a previously scanned barcode, leading to a glucose result being assigned to the wrong patient's medical record.

High risk, FDA, Software defect

Bard Access Systems DuoGlide and Power-Trialysis Short-Term Straight Dialysis Catheter

Bard Access Systems is recalling its Power-Trialysis Short-Term Straight Dialysis Catheter because this is a downstream recall of class I recall RES 98777.

High risk, FDA, Device defect

ICU Medical IV and Oncology Administration Sets

ICU Medical IV and Oncology Administration Sets may have black specks in their drip chambers.

Moderate risk, FDA, Foreign object

2 recalls that day

Windstone Medical Packaging AMS Convenience Kit DSAEK Pack

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags.

Moderate risk, FDA, Device defect

MedicaLyte and Citric Complete Concentrates

MedicaLyte and Citric Complete Concentrates contain high endotoxin levels.

Moderate risk, FDA, Contamination

1 recall that day

Medical Action Industries Epidural Kits

Epidural and pain kits containing sodium chloride ampules may have compromised sterility.

High risk, FDA, Sterility problem

5 recalls that day

Getinge PVC Thoracic Catheter

Getinge PVC Thoracic Catheters may contain too much bacterial endotoxin.

Moderate risk, FDA, Quality testing problem