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Medical device recalls

Medical device recalls from FDA, newest first.
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7 recalls

Fujirebio Lumipulse G Plasma Assays, Calibrators and Controls

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging.

Moderate risk, FDA, Device defect

Boston Scientific AXIOS and HOT AXIOS Stent and Delivery Systems

AXIOS Stent and Electrocautery-Enhanced Delivery Systems may have deployment and expansion issues.

High risk, FDA, Device defect

Wilson-Cook Nasal Jejunal Feeding Tube

The nasal jejunal feeding tube is packaged without the nasal transfer tube component.

Moderate risk, FDA, Device defect

2 recalls

Changchun Wancheng Bio-Electron Urine Test Strips and Cassettes

Changchun Wancheng Bio-Electron Urine Test Strips and Cassettes may cause false or inaccurate diagnostic results by lay persons.

Moderate risk, FDA, Device defect

Vortex Surgical Ophthalmic Surgical Instruments

Volk Single Use Vitrectomy Lenses may have voids in the seal of Tyvek pouches, which could lead to infection.

Moderate risk, FDA, Sterility problem

2 recalls

Focalyx Technologies Focalyx Fusion

Focalyx Fusion is a software device for image-guided prostate procedures.

Moderate risk, FDA, Software defect

Siemens SOMATOM X.Ceed and NAEOTOM Alpha Software Applications

CT software applications lack FDA clearance and may be removed from certain systems.

Moderate risk, FDA, Software defect

7 recalls

VITEK 2 Gram-negative Susceptibility Cards

Issue may lead to QC failure or false resistant results.

Moderate risk, FDA, Device defect

Vantive Prismaflex and Oxiris Dialyzer Sets

The Prismaflex Set deaeration chamber may dislodge from the Control Unit.

Moderate risk, FDA, Device defect

Encore Medical EMPOWR Knee and Hip Implants

Empowr Acetabular System and Empowr 3D Knee Tibial Insert may have a packaging discrepancy that could cause surgical delay or revision surgery.

Moderate risk, FDA, Packaging defect

Medtronic MiniMed 780G Insulin Pump

A software issue may cause Pump Error 43 or 41, suspending insulin delivery.

Moderate risk, FDA, Software defect

Da Vinci X, Xi, and 5 Surgical Systems

The da Vinci surgical systems have a software error that can allow failing instrument arms to remain in use.

Moderate risk, FDA, Software defect

Tornier Perform Reversed Perip Screw

Screws labeled 5.0mmx18mm are actually 5.00mmx14mm, which may cause a delay or increase risk of failure.

Moderate risk, FDA, Labeling error

Beckman Coulter CellMek SPS Sample Preparation System

The CellMek SPS Sample Preparation System has a software error that can cause sample loss and incorrect diagnosis.

Moderate risk, FDA, Software defect

2 recalls

Beckman Coulter DxH Diluent and DxH ECO Diluent

Coulter DxH Diluent and ECO Diluent can cause elevated platelet background counts with use.

Moderate risk, FDA, Device defect

Olympus Single Use Electrosurgical Knives KD-640L and KD-645

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Moderate risk, FDA, Device defect

5 recalls

BD Alaris Pump Module Model 8100

The BD Alaris Pump Module may have a date and time issue causing connectivity problems with hospital networks.

Moderate risk, FDA, Device defect

Philips Ingenia, MR 7700 and Evolution MR Systems

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Moderate risk, FDA, Device defect

LimFlow Vector

The LimFlow Vector has an incorrect expiration date.

Moderate risk, FDA, Labeling error

LSL Healthcare Central Line Dressing Kit

The Central Line Dressing Kit contains BD ChloraPrep Triple Swabsticks with an open seal on the applicator packaging.

Moderate risk, FDA, Device defect

Miach Orthopaedics BEAR Implant

The BEAR Implant has an incorrect expiration date on its label.

Moderate risk, FDA, Labeling error

4 recalls

Broselow Pediatric Emergency Tape and Organizers

Broselow Pediatric Emergency Tape and Organizers contain potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

High risk, FDA, Device defect

Medline Medical Procedure Convenience Kits

Medline medical procedure convenience kits contain a liquid adhesive whose tubing can crack during actuation.

Moderate risk, FDA, Device defect

Cardinal Health Chest Drainage Units and Accessories

Chest drainage units may not show tidaling or bubbling when used on infants, which could lead to inadequate treatment.

Moderate risk, FDA, Device defect

Zimmer Tourniquet Systems A.T.S. 5000TS and 3200TS Tourniquet Systems

Zimmer A.T.S. 5000TS and 3200TS Tourniquet Systems may freeze or become unresponsive to touch in certain non-English language settings.

Moderate risk, FDA, Device defect

4 recalls

Canon Alphenix Interventional Fluoroscopic X-Ray Systems

As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed.

Moderate risk, FDA, Device defect

NIPRO Conductivity Standard Solutions

Conductivity Standard Solution has a defect that can cause incorrect conductivity values for dialysate.

Moderate risk, FDA, Device defect

Gold Star Distribution Bandages, Condoms, Feminine Hygiene Products, Toothbrushes and Pregnancy Tests

Gold Star Distribution tests may have been exposed to rodents and rodent activity.

Moderate risk, FDA, Foreign object

Siemens LUMINOS Q.Namix R and Q.Namix T Interventional Fluoroscopic X-Ray Systems

Interventional fluoroscopic X-ray systems may not flip ortho images and could process a previous patient's image.

Moderate risk, FDA, Device defect

1 recall

Aju Pharm Fixone, Genesis and AlternatiV+ Anchors

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Moderate risk, FDA, Device defect

2 recalls

Elekta Synergy, Harmony, Infinity and Versa HD Linear Accelerators

The digital linear accelerators have a manufacturing issue with electrical grounding.

Moderate risk, FDA, Manufacturing problem

Cerapedics PearMatrix P-15 Peptide Enhanced Bone Graft

The bone graft has an incorrect expiration date.

Moderate risk, FDA, Labeling error

4 recalls

Edan Fetal, Maternal, Vital Signs and Patient Monitors

As a result of receiving an FDA It Has Come to Our Attention Letter (Ihctoa Letter) regarding potential cybersecurity issues with various of the firm device.

Moderate risk, FDA, Software defect

Community Products Rifton Equipment TRAM and E-Pacer Powered Lifts

The TRAM and E-Pacer have a potential for fraying on the body support strap.

Moderate risk, FDA, Device defect

GVS TM SQ40S Blood Transfusion Filter

The SQ40S Blood Transfusion Filter was released before quality control was complete, so sterility cannot be confirmed.

Moderate risk, FDA, Sterility problem

Philips Patient Information Center iX

The Patient Information Center iX software can modify event notification settings without user indication.

Moderate risk, FDA, Software defect

3 recalls

Beckman Coulter LDL-Cholesterol Assay

Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU).

Moderate risk, FDA, Device defect

Sysmex America TS-10/TS-10H Tube Sorter

The TS-10/TS-10H Tube Sorter may unexpectedly disengage its lift, causing unintended downward movement.

Moderate risk, FDA, Device defect

Intuitive Surgical Ion Endoluminal System Vision Probe Bags

The Ion Vision Probe Bag may have a compromised or incomplete sterile pouch seal.

Moderate risk, FDA, Sterility problem

2 recalls

Tyber Medical VOLT Wrist Treatment System Distal Radius Plates

The VOLT Wrist Treatment System plates have incorrect thread orientation, which can cause a problem.

Moderate risk, FDA, Device defect

MicroPort HIPTURN Fem Head Trial 36mm Reusable

The Hipturn FEM Head Trial 36MM Reusable lacks FDA premarket authorization for U.S. distribution.

Moderate risk, FDA, Device defect

11 recalls

Olympus ViziShot 2 FLEX (19G) EBUS -TBNA Needles

ViziShot 2 Flex needles can eject or detach components during procedures, risking injury or death.

FDA

Philips Azurion System

Issue 1 - System remains in continuous restart mode after the start-up.

Moderate risk, FDA, Software defect

RaySearch Laboratories RayStation/RayPlan Radiation Therapy Treatment Planning Systems

RayStation/RayPlan radiation therapy treatment planning system may not invalidate calculated radiation dose for certain regions of interest.

Moderate risk, FDA, Device defect

ICU Medical Plum Duo and Plum Solo Infusion Pumps

ICU Medical Plum Duo and Plum Solo Infusion Pumps can prevent programming a piggyback flush, causing a violation message.

Moderate risk, FDA, Software defect

Merit Medical Inflation Devices and Custom Kits

Inflation device handle may detach from the syringe during procedure.

Moderate risk, FDA, Device defect

ICU Medical Tego Connector

The Tego Connector has a silicone seal that may bulge, separate, or tear, causing fluid leaks and therapy interruption.

Moderate risk, FDA, Contamination

Baxter SIGMA Spectrum Infusion Pump

The SIGMA Spectrum Infusion Pump has defective grease that may cause over-infusion or free-flow.

Moderate risk, FDA, Device defect

Leaseir MHR Xcell Surgical Laser Instruments

The Leaseir MHR Xcell surgical laser instrument is missing the Danger symbol on its console label.

Moderate risk, FDA, Labeling error

Medline Semi Electric and Full Electric Homecare Beds

Medline beds have a potential hazard involving the hand control pendant and wires, which may overheat and pose a fire risk.

High risk, FDA, Device defect