Skip to main content
RecallsAboutBlog

Medical device recalls

Medical device recalls from FDA, newest first.
Filters · 1Sort Newest
Agency
Risk level
Date
Sold in

2 recalls

Ziehm-Orthoscan VERSA Accessory Cart and Versa Mini C-Arm System

The accessory cart and mini C-arm system have a weld that may fail, causing the monitor arm to separate.

Moderate risk, FDA, Device defect

Medtronic OmniaSecure Model 3930M Leads

Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation.

Moderate risk, FDA, Device defect

7 recalls

Medline C-Section Drapes and Medical Convenience Kits

Medline C-Section Drapes and Medical Convenience Kits are difficult to remove from the patient and leave adhesive residue on the patient's skin.

Moderate risk, FDA, Device defect

Solstice Xact Mole Marker for Mammography

The Xact mole marker for mammography may have its radiopaque material detach, causing artifacts.

Moderate risk, FDA, Device defect

Medtronic InterStim SureScan MRI Leads and Percutaneous Extensions

Wrong lead or percutaneous extension selected.

Moderate risk, FDA, Device defect

Medtronic MiniMed Go App

The MiniMed Go app has a software defect that can cause missed or delayed insulin doses, potentially leading to hyperglycemia or hypoglycemia.

Moderate risk, FDA, Software defect

restor3d MTP Implants

The restor3d MTP Implant may not have been sterilized, as shown by orange sterilization indicators.

Moderate risk, FDA, Device defect

CooperVision Softmed Breathables Advanced Toric Contact Lenses

The contact lens is labeled for extended wear but is intended for daily wear only.

Moderate risk, FDA, Unapproved product

Boston Scientific Direxion Torqueable Microcatheters

The Direxion Torqueable Microcatheter is defective due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

Moderate risk, FDA, Device defect

2 recalls

Beckman Coulter Rotor SW40 and SW41

Beckman Coulter Rotor SW40 and SW41 may break into two or more pieces.

Moderate risk, FDA, Device defect

VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator

Blood collection tubes may contain EDTA contamination, leading to falsely elevated potassium and decreased calcium results.

Moderate risk, FDA, Contamination

1 recall

Ventec Life Systems VOCSN, V+Pro, VC and V*Home Ventilators

The ventilator's internal flow transducer cable connector may disconnect from the internal board.

High risk, FDA, Device defect

6 recalls

Philips Smart-Hopping 2.0 AP 1.4 GHz

Philips Smart-hopping 2.0 AP 1.4 GHz has unreliable wireless roaming behavior that can cause loss of connectivity to the central monitoring system.

Moderate risk, FDA, Device defect

Medtronic NDI Passive Spheres and Biopsy Needle Kit

Medtronic NDI Passive Spheres and Biopsy Needle Kit have variation in reflective material that may affect navigation tracking.

Moderate risk, FDA, Device defect

B Braun SAFSITE Injection Site

The B Braun Safsite Injection Site has a potential for leakage and backflow.

Moderate risk, FDA, Device defect

Philips Lumify Diagnostic Ultrasound System

The Philips Lumify Diagnostic Ultrasound System may not recognize transducer registration, prevent scanning, or have unstable connections.

High risk, FDA, Device defect

Abbott Amplatzer Amulet Left Atrial Appendage Occluder

The Amplatzer Amulet Left Atrial Appendage Occluder has changes to its instructions regarding risk of pulmonary artery injury.

Moderate risk, FDA, Device defect

Axonics PNE Lead Implant Kit

The PNE Lead Implant Kit may leak, break, or experience other issues that may pose a risk to users.

Moderate risk, FDA, Device defect

7 recalls

Healthmark Vinyl Instrument Guards

Vinyl Instrument Guards have labeling that is not compliant with regulations and updated sterilization instructions.

Moderate risk, FDA, Labeling error

Merit Medical Systems Scout MD Delivery System

The Scout MD Delivery System may have difficulty deploying, which could prevent the reflector from functioning.

Moderate risk, FDA, Device defect

Intelerad IntelePACS and InteleConnect Portal Radiological Image Processing Systems

IntelePACS and InteleConnect Portal/Tech Portal may show report and displayed images that do not match.

Moderate risk, FDA, Device defect

Medline Surgical Convenience Kits

Medline surgical convenience kits contain cannula components that may leak or break during use.

Moderate risk, FDA, Device defect

Cook Williams Cystoscopic Injection Needles

Williams Cystoscopic Injection Needles may have a misaligned Luer lock adapter, increasing procedural time and causing inadequate treatment.

Moderate risk, FDA, Device defect

Beckman Coulter DxU 840m Iris, DxU 850m Iris, IQ200 Sprint Analyzers

The DxU 840m Iris, DxU 850m Iris, IQ200 Sprint, IQ200 Select, and IQ200 Elite may leak lamina fluid, posing slip, chemical.

Moderate risk, FDA, Device defect

Radiometer Medical ABL90 FLEX and ABL90 FLEX PLUS Analyzers

The ABL90 Flex and ABL90 Flex Plus analyzers have a risk of potentially inaccurate results.

Moderate risk, FDA, Device defect

3 recalls

In2bones CoLag Screw FT

Bone screws labeled as fully threaded are actually partially threaded.

Moderate risk, FDA, Labeling error

Steris Rapicide PA Part A High-Level Disinfectant

Rapicide PA Part A High-Level Disinfectant may swell if its vented cap is blocked, and could expose users to vapor or liquid.

Moderate risk, FDA, Device defect

Ethicon PERMA-HAND Silk Surgical Suture

PERMA-HAND Silk surgical sutures may contain alcohol-based fluid, causing surgical delay or tissue irritation.

Moderate risk, FDA, Device defect

2 recalls

Baxter Likorall Overhead Lifts

Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.

Moderate risk, FDA, Device defect

BioFire FilmArray Pneumonia and Joint Infection Panels

BioFire Diagnostics is recalling 3 products.

Moderate risk, FDA, Device defect

1 recall

Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)

The HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.

High risk, FDA, Device defect

7 recalls

SI-BONE iFuse TORQ Implant System

The iFuse TORQ Implant System may not be sterile because its packaging seal integrity was not assured.

Moderate risk, FDA, Sterility problem

Ferno-Washington Power F2 Powered Fastening System

The Power F2 Powered Fastening System may have intermittent loss of powered function, causing reduced performance or delays in patient transport.

Moderate risk, FDA, Software defect

Boston Scientific NaviFlex LW Pusher and Advx Panc Stent

The device was incorrectly manufactured with a guidewire exit port, which is not a design feature.

Moderate risk, FDA, Device defect

Neuronetics NeuroStar Advanced Therapy Systems

The NeuroStar Advanced Therapy System has cables that are not in conformance with product specifications.

Moderate risk, FDA, Device defect

Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312

BD Phoenix Panel NMIC-312 may have quality control failures with Klebsiella pneumoniae.

Moderate risk, FDA, Device defect

Medtronic Grafton DBM and Grafton Plus DBM Bone Grafts

Grafton DBM and Grafton Plus DBM may cause infection if implanted.

Moderate risk, FDA, Sterility problem

JenaValve Trilogy Delivery Catheters

The JenaValve Trilogy Delivery Catheter may have sleeve liner separation that can cause difficulty or inability to deploy the heart valve device.

Moderate risk, FDA, Device defect

5 recalls

Steris HexaVue Focus Integration System

HexaVue Focus Integration System may mismatch patient information on manually printed images, causing documentation discrepancies.

Moderate risk, FDA, Software defect

LeMaitre Vascular TufTex Over-the-Wire Embolectomy Catheter

The TufTex Over-the-Wire Embolectomy Catheter can fail under pull force, causing balloon components to fail.

Moderate risk, FDA, Device defect

Mindray Patient Monitors and Telemetry Monitoring Systems

The ePM Series Patient Monitor has manual descriptions that may be insufficient or require clarification regarding alarm functions.

Low risk, FDA, Device defect

Polymedco Sediplast

Sediplast tubes may resist insertion, causing cap ejection and blood exposure.

Moderate risk, FDA, Device defect

AVID Medical Custom Surgical Procedure Kits

Davinci Trucustom Bundle may be contaminated with a lubricant used during manufacturing.

Moderate risk, FDA, Contamination

1 recall

Nihon Kohden CNS-6200 Series Central Nurse Station

The Nihon Kohden CNS-6200 Series Central Nurse Station has a cybersecurity issue that could disrupt monitoring and alarm visualization.

Moderate risk, FDA, Software defect

2 recalls

Medtronic MiniMed Flex Insulin Pumps

The MiniMed Flex insulin pump may have failed verification tests, leading to issues such as inaccurate insulin delivery.

Moderate risk, FDA, Device defect

Medline Bariatric Steel Rollators

The rollator's front fork stem bolt/wheel assembly may disconnect, causing the front wheels to detach and risk severe falls.

Moderate risk, FDA, Device defect

5 recalls

Safeguard US Operating Battle Bandage

The compression bandage may be degraded, which may cause unwanted foreign material inside the wound, leading to infection.

Moderate risk, FDA, Foreign object

Glypto Device, Glypto Cryo Machine

The Glypto Device and Glypto Cryo Machine lack 510(k) clearance.

Moderate risk, FDA, Unapproved product

Beckman Coulter DxC 500 Clinical Chemistry Analyzers

DxC 500 AU and DxC 500i analyzers have a software issue that can revert test units to default without warning, causing falsely elevated results.

Moderate risk, FDA, Software defect

Spectral CT and Spectral CT 7500 RT

Spectral CT and Spectral CT 7500 RT have software issues that may affect safety and performance.

Moderate risk, FDA, Software defect