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Medical device recalls

Medical device recalls from FDA, newest first.
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4 recalls

Acumed Hexalobe Screws

Acumed Hexalob Screws may break during use due to a manufacturing error.

Moderate risk, FDA, Manufacturing problem

Zimmer Off-Axis Comprehensive Shoulder System Reamer Guides

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Moderate risk, FDA, Device defect

PFM Medical Multi-Snare Sets

The Multi-Snare Set failed to meet biocompatibility requirements, which could cause localized inflammation and tissue irritation.

Moderate risk, FDA, Device defect

Ventec Life Systems VOCSN+Pro Package

The VOCSN+Pro respiratory system may have a damaged backup battery, causing the backup alarm not to activate during power loss.

Moderate risk, FDA, Device defect

3 recalls

Philips Avalon Fetal Monitor

The Philips Avalon Fetal Monitor has incorrect speaker connector assembly that can cause loss of speaker output.

Moderate risk, FDA, Device defect

Intuitive Surgical Da Vinci PSS SP1098

The Da Vinci Assy, PSS, SP1098 may have a retainer pin issue that can cause uncontrolled motion.

Moderate risk, FDA, Device defect

TMJ Solutions Bilateral Implants

Custom temporomandibular joint implant may have contained incorrect patient-specific components, leading to a poor fit and a right-sided open bite.

Moderate risk, FDA, Device defect

8 recalls

Datex-Ohmeda Giraffe and Panda Infant Resuscitation Systems

The Giraffe Stand-alone Infant Resuscitation System can deliver an oxygen concentration that does not match the intended setting.

High risk, FDA, Device defect

HeartMate 3 Left Ventricular Assist System Kits, System Controller, and Backup Battery

Due to 11 volt Backup Battery failures.

Moderate risk, FDA, Device defect

STAAR ICL Calculation Software

The STAAR ICL Calculation Software has a coding issue that affects the implant orientation diagram printout.

Moderate risk, FDA, Software defect

Inspire Respiratory Sensing and Stimulation Lead

The Inspire Respiratory Sensing Lead has an incorrect Use By Date, which may lead to unplanned revision surgery.

Moderate risk, FDA, Labeling error

Impella CP Set with SmartAssist

Impella CP Set with SmartAssist can cause low purge pressure alarms and loss of circulatory support.

High risk, FDA, Device defect

BD Connecta Stopcocks

BD Connecta BD Luer-Lok 360 Stopcocks may have an unstable connection at Port C when used with a plastic luer-lok syringe.

Moderate risk, FDA, Device defect

Merit Medical Systems Splashwire Hydrophilic Guide Wire

The Splashwire Hydrophilic Guide Wire has unsealed portions of pouches.

Moderate risk, FDA, Packaging defect

Beta Bionics iLet Bionic Pancreas

This can lead to hyperglycemia.

Moderate risk, FDA, Software defect

5 recalls

Howmedica Osteonics Tri TS Baseplate

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

Moderate risk, FDA, Labeling error

Medline Urethral Catheters and Procedure Kits

Medline urethral catheters and kits may have surface irregularities or connector issues.

Moderate risk, FDA, Quality testing problem

GE HealthCare Giraffe OmniBed Devices

The Giraffe OmniBed has a potential issue with the canopy soffit that could cause patient injury.

Moderate risk, FDA, Device defect

ConMed AirSeal Access Ports and Obturators

ConMed AirSeal Access Port and Obturator may cause overpressure alerts.

Moderate risk, FDA, Device defect

Mito Red Light Super Mobile

The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

Moderate risk, FDA, Device defect

4 recalls

Philips MultiDiagnost Eleva and Allura Xper Systems

Philips MultiDiagnost Eleva and Allura Xper systems have a hand switch button that may not fully release.

Moderate risk, FDA, Device defect

AMD Medicom Ritmed Neurological Sponges

Ritmed Neurological Sponges may not consistently meet endotoxin specification for devices that contact cerebrospinal fluid.

Moderate risk, FDA, Contamination

DirectCHECK ACT-LR Whole Blood Quality Control, Level 2

The whole blood quality control has labeling with an incorrect performance range.

Moderate risk, FDA, Labeling error

Smith & Nephew Trigen Proximal Straight Humeral Nail

The humeral nail is missing distal holes and may lead to revision surgery if implanted.

Moderate risk, FDA, Manufacturing problem

3 recalls

Medtronic O-Arm O2 Imaging System

The O-arm O2 Imaging System may show image artifacts due to a detector panel firmware anomaly.

Moderate risk, FDA, Software defect

ALYON and HarmonyAIR A-Series Surgical Lighting System

The surgical lighting system has light intensity control buttons that may detach.

Moderate risk, FDA, Device defect

HarmonyAIR A-Series Surgical Lighting System

The HarmonyAIR A-Series Surgical Lighting System has paint that may chip or peel on its light heads.

Moderate risk, FDA, Device defect

1 recall

Arrow International Vascular Access and Catheterization Kits

Paracentesis kits contain lidocaine, bupivacaine.

High risk, FDA, Sterility problem

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

8 recalls

Fresh Roast Systems ColorTrack

The Fresh Roast Systems ColorTrack could allow human access to infrared laser light levels in excess of its safety classification.

Moderate risk, FDA, Device defect

Halyard Pain, Towel, Drape and Eye Bag Packs

Halyard, Pain Pack contains sealed pouches that had not undergone validated sterilization.

Moderate risk, FDA, Sterility problem

MOSAIQ Oncology Information System

MOSAIQ Oncology Information System software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.

Moderate risk, FDA, Software defect

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 Clik X Anchor

The Clik X Anchor may lack sterility assurance.

Moderate risk, FDA, Sterility problem

Boston Scientific CSK and TCN Electrodes

Boston Scientific CSK Electrodes may not meet expected performance levels.

Moderate risk, FDA, Device defect

Fresenius Medical Care Holdings Bicarby Dialysate

Bicarby Dialysate has an error in the labeling of the GTIN, which may lead to unrecognized use of a potassium solution with a differing concentration.

Moderate risk, FDA, Labeling error

3 recalls

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit

Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel, which misidentifies the product and has different first aid instructions.

Moderate risk, FDA, Device defect

DT MedTech Hintermann Series Talar Implant

The Hintermann Series Talar Implant, Left, Size 2 has incorrect packaging labeling a right implant device.

Moderate risk, FDA, Labeling error

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

3 recalls

Medartis APTUS Cannulated Compression Screws

Cannulated Compression Screws for bone fixation have an off-center cannulation.

Moderate risk, FDA, Device defect

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

1 recall

NeoSpan SuperElastic Compression Staple w/Instruments

The NeoSpan SuperElastic Compression Staple w/Instruments is missing the Magnetic Resonance Conditional Symbol on its packaging and labels.

Moderate risk, FDA, Labeling error

11 recalls

DigitalDiagnost C90 Flex/Value/Chest/ER

The DigitalDiagnost C90 Flex/Value/Chest/ER was delivered without a required seismic kit for its Wall Stand VS2.

Moderate risk, FDA, Device defect

Micromed S.p.A. Natus SD LTM 64 PLUS EEG Amplifier/recorder

The SD LTM 64 PLUS EEG amplifier may show a 1-second delay between channels, potentially leading to misinterpretation of results.

Moderate risk, FDA, Software defect

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