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Medical device recalls

Medical device recalls from FDA, newest first.
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11 recalls

Allia Angiographic X-Ray System

The Allia IGS 3 Pulse angiographic X-ray system has an electrical cable issue that could cause electrical shock to service personnel.

Moderate risk, FDA, Device defect

Fresenius Medical Care Bicarby Dialysate

Bicarby Dialysate can leak during preparation, posing a slip and fall hazard.

Moderate risk, FDA, Device defect

Plum Duo Infusion, Duo Precision IV, and Solo Precision IV Pump

The Plum Solo Precision IV Pump may not display a soft limit alert, potentially leading to under- or over-delivery.

Moderate risk, FDA, Device defect

D.O.R.C. TDC VELOCE Two Dimensional Cutters

TDC Veloce cutters have a loose outer knife that can become loose during use.

Moderate risk, FDA, Device defect

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves

The blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

Moderate risk, FDA, Labeling error

Sporetraq Mail-In Spore Testing Service

Due to incorrect incubation process being performed on product.

Moderate risk, FDA, Processing problem

6 recalls

Siemens Artis Pheno and Artis Icono Interventional Fluoroscopic X-Ray Systems

These interventional fluoroscopic x-ray systems may show a 0 dose while actually applying x-ray to the patient.

Moderate risk, FDA, Device defect

Draeger Atlan A350 and A350XL Anesthesia Workstations

The Atlan A350 anesthesia workstation indicated a failure of the piston ventilator before use or suffered a failure of mechanical ventilation during use.

High risk, FDA, Device defect

SSC- Surgical Specialties Sharpoint Microsurgical Knife

3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

Moderate risk, FDA, Labeling error

KayserBett IDA Pediatric Care Bed

The pediatric care bed can be operated by a child if not locked, leading to serious injury or death.

High risk, FDA, Device defect

Grace Medical Stapes Prosthesis

The stapes prosthesis has incorrect functional length on its labeling.

Moderate risk, FDA, Labeling error

Da Vinci 5

The Da Vinci 5 system tower can unintentionally activate its near infrared handheld camera when turning off illumination.

Moderate risk, FDA, Device defect

7 recalls

DeRoyal Covaderm Plus Vascular Access Dressings

Covaderm Plus, Vascular Access Dressing lacks sterility assurance.

Moderate risk, FDA, Sterility problem

Aligned Medical Fluids Kit

The Aligned Medical AMS16835 Fluids Kit RX contains lidocaine hydrochloride injection with quality issues.

Moderate risk, FDA, Device defect

Fresenius Kabi Ivenix Infusion System LVP Software

The LVP software of the Ivenix Infusion System can report a false battery-health value and trigger a battery-depletion alarm.

High risk, FDA, Software defect

GE MAC 5 Resting ECG Analysis Systems

Software in development was made available for customer use, which can associate clinical information with the incorrect patient.

Moderate risk, FDA, Software defect

CareFusion 303 BD Pyxis Medication Cabinets

BD Pyxis medication cabinets have a fingerprint scanner that may overheat and cause first-degree burns.

Moderate risk, FDA, Device defect

Bayer Avanta Multi-Patient Administration Tube Sets

Avanta Multi-Patient Administration Tube Sets have a fit issue with the valve interface, causing unstable connection.

Moderate risk, FDA, Device defect

B. Braun Spinal Needle Procedure Kits

Spinal Needle procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP, with potential quality issues.

High risk, FDA, Device defect

3 recalls

Arvis Hip & Knee 2.0 and 3.0 Instrument Set

The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

Moderate risk, FDA, Device defect

Shimadzu Digital Angiography and Radiography Systems

Digital Angiography Systems and a Digital Radiography System have electromagnetic contactors that may weld together.

Moderate risk, FDA, Device defect

Daavlin Phothera 200 Phototherapy Devices

Phothera 200 Phototherapy Devices have calibration certificates with reversed outputs.

Moderate risk, FDA, Device defect

6 recalls

PhaseOne Antimicrobial Solution

PhaseOne Antimicrobial Solution has corrosion of its internal spring, which may cause discoloration and trace metals in the solution.

Moderate risk, FDA, Foreign object

CASE v7.0 Cardiac Testing System

The CASE v7.0 Cardiac Testing System can spark at the printer head, potentially causing serious thermal injury.

Moderate risk, FDA, Device defect

Advanced Bionics HiResolution Bionic Ear System Cochlear Implants

The HiResolution Bionic Ear System has an incorrect shelf-life expiration date.

Moderate risk, FDA, Labeling error

Neptune Smart Docking Station

The Neptune Smart Docking Station may not have completed required testing and poses a risk of electrical shock.

Moderate risk, FDA, Device defect

Covidien EndoStitch Polysorb Single Use Loading Unit

The Covidien EndoStitch Polysorb Single Use Loading Unit may have holes in its pouch, compromising the sterile barrier.

Moderate risk, FDA, Sterility problem

Philips Azurion 3M12, 3M15, 5M12 and Other Angiography Systems

Philips Azurion systems may show a dark image during Roadmap Pro, not clinically usable.

Moderate risk, FDA, Device defect

7 recalls

Fresenius Kabi Ivenix Infusion System (IIS), Large Volume Pump

The Ivenix Large Volume Pump can be damaged by dropping or jarring, causing unintended touchscreen behavior.

High risk, FDA, Device defect

B. Braun Anesthesia and Catheter Trays

The Cesk Northside Anesthesia Tray has a potential cracking of the butyrate tubing, rendering it unusable.

Moderate risk, FDA, Device defect

Covidien Mon-a-Therm Temperature Probes and Esophageal Stethoscope

Covidien Mon-a-Therm temperature probes lack FDA clearance.

Moderate risk, FDA, Unapproved product

Exacta Mix Vented Micro-Volume Inlet

Exacta Mix Vented Micro-Volume Inlet tubing sets may contain incorrect filters, causing reduced flow and clinical effects.

Moderate risk, FDA, Device defect

Becton Dickinson & Company BD Spinal Trays

BD Spinal Trays with Quincke or Whitacre needles have quality deficiencies related to acceptance testing.

High risk, FDA, Device defect

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula

The Shiley Tracheostomy Tube has incorrect display box labeling.

Moderate risk, FDA, Labeling error

Fresenius Kabi Ivenix Infusion System Large Volume Pump

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) has a cassette loading lever that can break.

Moderate risk, FDA, Device defect

6 recalls

GE HealthCare Carescape Telemetry Server

GE HealthCare CARESCAPE Telemetry Server can have a persistent NO COMM or OFF NETWORK condition, potentially causing loss of ECG and SpO2 monitoring.

Moderate risk, FDA, Device defect

Medtronic 1x4 and 2x4 Pocket Adaptor Kit for Deep Brain Stimulation

The Medtronic Pocket Adaptor Kits are labeled with incorrect Use-By-Dates.

Moderate risk, FDA, Labeling error

Medline Eye Tray-LF Medical Convenience Kit

The Medline Eye Tray-LF kit contains syringes labeled as 1 mL but are U-100 insulin syringes.

Moderate risk, FDA, Labeling error

Medline Anesthesia and Spinal Trays

Medline kits containing Huons Bupivacaine in Dextrose Injection have quality issues, including data integrity concerns and efficacy complaints.

High risk, FDA, Device defect

Philips Azurion and Allura Systems

The Azurion system may show decreased performance as it ages, potentially causing loss of imaging functionality.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The Automated Impella Controller has alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing.

High risk, FDA, Device defect

1 recall

HydroMARK Breast Biopsy Site Marker

The HydroMARK Breast Biopsy Site Marker has incorrect inner package labeling.

Moderate risk, FDA, Labeling error

2 recalls

Omnipod 5 Pods, Omnipod DASH Pod, and Omnipod (Eros) Pod

Omnipod insulin pods may leak insulin due to cannula damage, causing under-delivery and high blood glucose.

High risk, FDA, Device defect

Dexcom G7 Continuous Glucose Monitoring System

Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used.

Moderate risk, FDA, Device defect

3 recalls

Halyard Purezero Ultraviolet Nitrile Exam Gloves

Nitrile exam gloves failed to meet chemical permeation performance specifications.

Moderate risk, FDA, Quality testing problem

Automated Impella Controller (AIC)

The Automated Impella Controller may interrupt motor control, have startup issues, or boot up improperly.

High risk, FDA, Device defect

RelayPro Thoracic Stent-Graft System

The RelayPro Thoracic Stent-Graft System may have a proximal clasp disconnection that prevents release from the delivery system.

High risk, FDA, Labeling error

3 recalls

Philips Azurion Systems

Philips Azurion systems may have table movements impacted due to mechanical wear of the Float Tabletop control.

Moderate risk, FDA, Device defect

Philips Azurion, Allura and Integris-Allura Systems

The Azurion system's deaeration hose may degrade, potentially causing oil leakage that affects cooling performance.

Moderate risk, FDA, Device defect

Silastic Foley Catheters

Silastic Foley Catheters have a stain on their surface.

Moderate risk, FDA, Device defect