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Medical device recalls

Medical device recalls from FDA, newest first.
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3 recalls

Boston Scientific Orca Single Use Air/Water and Suction Valves

Orca Single Use Air/Water and Suction Valves have a suction button that can stick.

Moderate risk, FDA, Device defect

Merlin Patient Care System (PCS)

Software malfunction may occur during pacing capture threshold test.

Moderate risk, FDA, Software defect

Boston Scientific CSK and TCN Electrodes

Boston Scientific CSK Electrodes may not meet expected performance levels.

Moderate risk, FDA, Device defect

1 recall

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC)

A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

Moderate risk, FDA, Device defect

2 recalls

EXENT Analyser

It was reported that plates 2 and 3 were marked as passed, although it appeared that QC had not been performed on these plates, despite samples being measured.

Moderate risk, FDA, Device defect

Sagemax Bioceramics NexxZr T Multi Dental Zirconia

NexxZr T Multi A3.5 W98-16mm dental discs may have a reduced or missing dentin layer, increasing fracture risk under stress.

Moderate risk, FDA, Device defect

5 recalls

Avanos Medical CORFLO and MIC Safety PEG Kits

Corflo and MIC Safety PEG Kits contain lidocaine hydrochloride injection that was recalled for quality issues.

Moderate risk, FDA, Sterility problem

Mahurkar Elite PASS Trays

Mahurkar Elite PASS Trays are missing the Tegaderm CHG dressing specified in product labeling.

Moderate risk, FDA, Labeling error

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

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

Sporetraq Mail-In Spore Testing Service

Due to incorrect incubation process being performed on product.

Moderate risk, FDA, Processing problem

2 recalls

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

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

3 recalls

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

2 recalls

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

3 recalls

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

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

1 recall

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

4 recalls

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 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

1 recall

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

2 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

1 recall

Medtronic Gundry and DLP Retrograde Cannulas

Medtronic retrograde cannulas may have a sterile barrier breach.

Moderate risk, FDA, Sterility problem

1 recall

Swan-Ganz Catheter

Swan-Ganz Catheters may leak or break at the blue proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Moderate risk, FDA, Device defect

3 recalls

Arrow Hemodialysis Catheters

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

High risk, FDA, Device defect

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 tricuspid delivery system has a labeling update to warn if its function is compromised.

Moderate risk, FDA, Labeling error

2 recalls

Philips Azurion

Philips Azurion has bolts and plastic parts that may loosen or break.

Moderate risk, FDA, Device defect

Hologic Selenia Dimensions and 3Dimensions Mammography Systems

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

Moderate risk, FDA, Device defect

1 recall

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

The Dexcom G7 CGM iOS App has a software defect that can delay glucose alerts.

Moderate risk, FDA, Software defect

2 recalls

GE HealthCare Revolution CT Scanners

GE HealthCare computed tomography systems have a potential security vulnerability that could impact AW Server via Edison Health Link.

Moderate risk, FDA, Software defect

Namic Manifolds and Kits

Namic Angiographic Manifolds contain particulate within the fluid path.

High risk, FDA, Foreign object

1 recall

Medline Convenience Kits, Surgical Drapes, Gowns and Packs

Medline Convenience Kits and Surgical Drapes may not be sterile due to calibration issues with sterilization equipment.

Moderate risk, FDA, Sterility problem

2 recalls

Mint Lesion

If the connection between a Mint Lesion workstation and the server is interrupted while performing a read, some information may be lost or incorrectly linked to other patients.

Moderate risk, FDA, Device defect

DEX Ophthalmic Tissue Forceps

DEX Ophthalmic Tissue Forceps have a field safety corrective action for their instructions for use.

Moderate risk, FDA, Device defect

6 recalls

Spacelabs Ultraview SL Command Module

The Spacelabs Ultraview SL Command Module has a manufacturing issue with its electrical leakage tester.

Moderate risk, FDA, Manufacturing problem

Cook Centimeter Sizing Catheters

Marker bands may be at an increased risk of cracking/breakage.

High risk, FDA, Device defect

Boston Scientific LUX-Dx II Arrhythmia Detectors and Alarms

The LUX-DX II Arrythmia detector and alarm may not collect PVC Burden data or monitor for Bradyarrhythmia and Pause.

Moderate risk, FDA, Software defect

Erbe ERBEFLO CleverCap CO2 Tubing and Cap Sets

The Erbeflo CleverCap CO2 Hybrid CO2 Tubing/Cap Set may allow unintended water flow, leading to water aspiration and respiratory failure.

Moderate risk, FDA, Device defect

Da Vinci X, Xi Surgical System

The da Vinci X and Xi surgical systems have screws in the arm that may break.

Moderate risk, FDA, Device defect

Intuitive 8 mm SureForm 30 Gray Reloads

The reloads may potentially produce an incomplete staple line.

High risk, FDA, Device defect

1 recall

Medline and Centurion Medical Convenience Kits

Medical convenience kits containing Webcol Large Alcohol Prep Pads may not be sterile due to a contaminant.

Moderate risk, FDA, Sterility problem