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FDA medical device recalls

Medical device recalls from FDA, newest first. 890 recalls Dates are when each recall was announced (how we date recalls).
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2 recalls that day

Focalyx Technologies Focalyx Fusion

The software device's accessories may not function properly with Windows 10.

Moderate risk, FDA, Software defect

Siemens SOMATOM X.Ceed and NAEOTOM Alpha Software Applications

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Moderate risk, FDA, Software defect

7 recalls that day

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

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Moderate risk, FDA, Device defect

Encore Medical EMPOWR Knee and Hip Implants

The 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 timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41.

Moderate risk, FDA, Software defect

Da Vinci X, Xi, and 5 Surgical Systems

The da Vinci surgical systems have a software error that let instrument arms fail a diagnostic test and remain in use.

Moderate risk, FDA, Software defect

Tornier Perform Reversed Perip Screw

The screws are incorrectly labeled as 5.0mmx18mm but are actually 5.00mmx14mm, which may cause a minor delay or increase risk of mechanical 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 that day

Beckman Coulter DxH Diluent and DxH ECO Diluent

The diluent can cause elevated platelet background counts when used with analyzers.

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 that day

BD Alaris Pump Module Model 8100

The BD Alaris Pump Module may have a date and time issue that can cause 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 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, extending beyond its approved shelf life.

Moderate risk, FDA, Labeling error

4 recalls that day

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 kits contain Mastisol liquid adhesive, and there were complaints that its butyrate tubing cracked during actuation of the vials.

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 can lead to inadequate treatment and prolonged hospitalization.

Moderate risk, FDA, Device defect

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

A.T.S. tourniquet systems may freeze or become unresponsive in certain non-English settings, causing delays.

Moderate risk, FDA, Device defect

4 recalls that day

Canon Alphenix Interventional Fluoroscopic X-Ray Systems

Alphenix Infx-8000C, Infx-8000F, Infx-8000H, and INFX-8000V interventional fluoroscopic x-ray systems may have loose fixing screws in the ceiling suspended arm.

Moderate risk, FDA, Device defect

NIPRO Technical Services 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

Ortho images acquired with preset automatic horizontal flip are not flipped.

Moderate risk, FDA, Device defect

1 recall that day

Aju Pharm Fixone, Genesis and AlternatiV+ Anchors

The Fixone Hybrid Anchor can fail, including breakage, bending, pull out, and suture breakage.

Moderate risk, FDA, Device defect

2 recalls that day

Elekta Synergy, Harmony, Infinity and Versa HD Linear Accelerators

Elekta Synergy, Harmony, Infinity, and Versa HD linear accelerators have a manufacturing issue with electrical grounding.

Moderate risk, FDA, Manufacturing problem

Cerapedics PearMatrix P-15 Peptide Enhanced Bone Graft

PearMatrix P-15 Peptide Enhanced Bone Graft has an incorrect expiration date.

Moderate risk, FDA, Labeling error

4 recalls that day

Edan Fetal, Maternal, Vital Signs and Patient Monitors

The devices have potential cybersecurity issues.

Moderate risk, FDA, Software defect

Community Products Rifton Equipment TRAM and E-Pacer Powered Lifts

The TRAM powered lift device has 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 required quality control was completed, so sterility cannot be confirmed.

Moderate risk, FDA, Sterility problem

Philips Patient Information Center iX

Patient Information Center iX software can modify filter settings without user indication.

Moderate risk, FDA, Software defect

3 recalls that day

Beckman Coulter LDL-Cholesterol Assay

The LDL Cholesterol reagent is not meeting its performance claim.

Moderate risk, FDA, Device defect

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

The TS-10/TS-10H Tube Sorter may allow unintended downward movement of the lift.

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 that day

VOLT Wrist Treatment System Distal Radius Plates

The 2.4/2.7 2Column Dist Radius Plate has an incorrect thread orientation.

Moderate risk, FDA, Device defect

MicroPort Orthopedics 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 that day

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

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

Not yet rated, FDA

Philips Azurion System

Two software issues may cause loss of imaging, motorized movement, incorrect image content, or loss of data.

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

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy.

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 other problems.

Moderate risk, FDA, Contamination

Baxter SIGMA Spectrum Infusion Pump

The SIGMA Spectrum Infusion Pump may have defective grease causing insufficient lubrication and potential over-infusion or free-flow.

Moderate risk, FDA, Device defect

Leaseir MHR Xcell Surgical Laser Instruments

The console label for affected devices is missing the "Danger" symbol.

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

Mazor Robotics Mazor X Robotic Guidance System

The Mazor X robotic guidance system has software errors that can result in incorrect surgical instrument positioning.

Moderate risk, FDA, Software defect

GE Healthcare Omni Legend PET Scanners

GE Healthcare Omni Legend can show a streaking artifact in PET scan images.

Moderate risk, FDA, Device defect

7 recalls that day

Thoratec CentriMag Blood Pump and Kits

The CentriMag blood pump may not fit into the motor and may not lock securely, which could lead to stroke, embolism, or death.

Moderate risk, FDA, Foreign object

Hologic ThinPrep CytoLyt Solution Buffered Cell Wash Solution

ThinPrep CytoLyt Solution is contaminated with Parengyodontium album.

Moderate risk, FDA, Contamination

ICU Medical Plum Duo Infusion System

The Plum Duo Infusion System may have a defective speaker that fails to produce audible sound.

Moderate risk, FDA, Device defect