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Medical device recalls

Medical device recalls from FDA, newest first.
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2 recalls

Medline Convenience Kits

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive.

Moderate risk, FDA, Device defect

Automated Impella Controller (AIC)

The Automated Impella Controller has a potential software error when used with left ventricular Impella devices.

High risk, FDA, Software defect

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

1 recall

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

6 recalls

CGuard Prime Carotid Stent System

The CGuard Prime Carotid Stent System may encounter complications during deployment, causing high resistance or inability to deploy.

Moderate risk, FDA, Device defect

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

3 recalls

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

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

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

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

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

5 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

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

5 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

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

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

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

1 recall

Automated Impella Controller (AIC)

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

High risk, FDA, Device defect

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

2 recalls

OneLIF Interbody Cage

The OneLIF Interbody Cage's inserter may fail to attach, causing procedural delays.

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

ICU Medical ChemoLock Oncology Kits and Transfer Sets

Oncology sets may leak, causing therapy interruption and possible exposure to hazardous substances.

Moderate risk, FDA, Device defect

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

4 recalls

Codman CerebroFlo EVD Catheter with Endexo Technology

The CerebroFlo EVD Catheter 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

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