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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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3 recalls that day

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 that day

PhaseOne Antimicrobial Solution

PhaseOne Antimicrobial Solution has a corroded internal spring that may discolor the solution and add trace metals.

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

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 that is not clinically usable during Roadmap Pro.

Moderate risk, FDA, Device defect

7 recalls that day

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

B. Braun anesthesia and catheter trays contain Mastisol Liquid Adhesive, whose tubing may crack, which renders the product unusable.

Moderate risk, FDA, Device defect

Covidien Mon-a-Therm Temperature Probes and Esophageal Stethoscope

Temperature probe devices lack FDA clearance.

Moderate risk, FDA, Unapproved product

Exacta Mix Vented Micro-Volume Inlet

Vented Micro-Volume Inlet tubing sets may contain incorrect filters, reducing flow efficiency and causing clinical effects.

Moderate risk, FDA, Device defect

Becton Dickinson & Company BD Spinal Trays

BD Spinal Tray with BD Quincke Needle has quality issues identified during an FDA inspection.

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 potential for the Cassette Loading Lever to break.

Moderate risk, FDA, Device defect

6 recalls that day

GE HealthCare Carescape Telemetry Server

With the Carescape Telemetry Server, a persistent No Comm or Off Network condition can result in potential loss of ECG and SpO2 monitoring.

Moderate risk, FDA, Device defect

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

The Pocket Adaptor Kits for Deep Brain Stimulation have incorrect Use-By-Dates.

Moderate risk, FDA, Labeling error

Medline Eye Tray-LF Medical Convenience Kit

The Medline medical convenience kit labeled as Eye Tray-LF contains syringes that are mislabeled.

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

A system restart may temporarily restore 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 that day

HydroMARK Breast Biopsy Site Marker

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

Moderate risk, FDA, Labeling error

2 recalls that day

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

Dexcom G7 sensors from two lots were stolen and sold, posing risks of skin infection or missed readings.

Moderate risk, FDA, Device defect

3 recalls that day

Halyard Purezero Ultraviolet Nitrile Exam Gloves

The 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 controls, cause startup failures, or lead to boot-up failure.

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 that day

Philips Azurion Systems

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

Moderate risk, FDA, Device defect

Philips Azurion, Allura and Integris-Allura Systems

The deaeration hose in X-ray tube cooling units may degrade over time, potentially resulting in oil leakage.

Moderate risk, FDA, Device defect

Silastic Foley Catheters

Silastic Foley Catheters have a stain on their surface.

Moderate risk, FDA, Device defect

2 recalls that day

OneLIF Interbody Cage

The OneLIF Interbody Cage may fail to attach to its inserter, causing procedural delay or need for an alternative implant.

Moderate risk, FDA, Device defect

Medtronic Gundry and DLP Retrograde Cannulas

Medtronic retrograde cannulas may have a sterile barrier breach.

Moderate risk, FDA, Sterility problem

1 recall that day

ICU Medical ChemoLock Oncology Kits and Transfer Sets

Oncology sets with extension sets may leak, causing therapy interruption and potential under-infusion.

Moderate risk, FDA, Device defect

2 recalls that day

Tangent Endoscopy Single Use Digital Catheter

The Tangent Single Use Digital Catheter can fracture at the distal shaft tip without complete detachment.

Moderate risk, FDA, Device defect

Swan-Ganz Catheter

Swan-Ganz Catheters may leak or break at the blue proximal injectate lumen hub, potentially causing infection, medication loss, or blood loss.

Moderate risk, FDA, Device defect

2 recalls that day

LVIS Intraluminal Support Device

The LVIS Intraluminal Support Device may have dimensional nonconformance or incorrect configuration, potentially causing vessel injury or neurological events.

Moderate risk, FDA, Device defect

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application

The Medtronic SynchroMed Flex Infusion Mode software may display infusion steps out of order, causing the schedule not to be delivered as intended.

Moderate risk, FDA, Software defect

5 recalls that day

Codman CerebroFlo EVD Catheter with Endexo Technology

The product has an out-of-specification endotoxin result that did not meet acceptance criteria.

Moderate risk, FDA, Quality testing problem

Arrow Hemodialysis Catheters

Arrow Hemodialysis Catheters may not split as intended, causing withdrawal resistance, pain, bleeding, and tissue injury.

High risk, FDA, Device defect

Omnicell i.v.Station Syringe Labels

Rolls of label stock used with the Omnicell i.v.Station may cause mislabeled syringes.

High risk, FDA, Labeling error

Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters

Reprocessed electrophysiology catheters have incomplete seals on sterile product.

Moderate risk, FDA, Sterility problem

Edwards EVOQUE Tricuspid Delivery System

The Edwards Evoque tricupid delivery system may have compromised functionality, which could affect the valve replacement.

Moderate risk, FDA, Labeling error

5 recalls that day

ZYMUTEST HIA IgG, in Vitro Diagnostic ELISA Kit

The Zymutest HIA IgG kit contains incorrect values for the positive control.

Moderate risk, FDA, Device defect

Philips Azurion

Philips Azurion systems have bolts and plastic parts that may loosen or break over time.

Moderate risk, FDA, Device defect

QuickVue Dipstick Strep A Test

The QuickVue Dipstick Strep A Test has the potential for false positive results.

Moderate risk, FDA, Device defect

Thermedx FluidSmart Urology Tube Set

The Thermedx FluidSmart Urology Tube Set is nonconforming due to inadvertent distribution.

Moderate risk, FDA, Device defect

Hologic Selenia Dimensions and 3Dimensions Mammography Systems

Hologic Selenia Dimensions and 3Dimensions Mammography Systems can develop loose, missing, or broken internal bolts over time.

Moderate risk, FDA, Device defect

3 recalls that day

Dexcom G7 CGM iOS, G7 CGM watchOS, and ONE+ iOS CGM App

Dexcom G7 CGM iOS, G7 CGM watchOS, and ONE+ iOS CGM App may perceive signal loss and deploy signal loss mitigations.

Moderate risk, FDA, Software defect

Technological Medical Advancements Diowave Laser System

The Diowave Laser System needs a software update because it operates at a maximum average power output of 70W, beyond the FDA cleared 60W.

Moderate risk, FDA, Software defect