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Medical device recalls

Medical device recalls from FDA, newest first.
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8 recalls

Accuray CyberKnife Treatment Delivery System and Linear Accelerator

The Cyberknife system's collimator may not fully dock, triggering an interlock and preventing motion.

Moderate risk, FDA, Device defect

Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators

Potential sterile breach of the pouches in which devices are packaged.

Moderate risk, FDA, Sterility problem

Hamilton Medical IntelliCuff Portable Automatic Cuff Pressure Controller

The IntelliCuff portable automatic cuff pressure controller may alarm with a leakage error and fail to maintain pressure.

Moderate risk, FDA, Device defect

Pilling Wecksorb Neurosponges and Neurosponge Strips

Pilling Wecksorb Neurosponges and Neurosponge Strips may have out-of-specification levels of endotoxins.

Moderate risk, FDA, Quality testing problem

2 recalls

Remel GC Agar Base

GC Agar Base may have reduced or no recovery of some strains of Neisseria gonorrhoeae.

Moderate risk, FDA, Device defect

Hamilton Medical Coaxial Breathing Circuit Sets

The coaxial breathing circuit may have expiratory valve membranes sticking, causing an exhalation obstructed alarm and inadequate ventilation.

High risk, FDA, Device defect

1 recall

Medline Convenience Kits

Medline Convenience Kits contain lidocaine ampules with quality issues that may affect their use.

Moderate risk, FDA, Device defect

1 recall

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Convenience kits with 10mL polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

4 recalls

Medline Convenience Kits

Medline Convenience Kits contain lidocaine and bupivacaine injections with quality issues.

High risk, FDA, Device defect

GE Healthcare AW Server 3.2 ext.6.5

The AW Server may open the previous patient's exam instead of the intended one, potentially leading to misdiagnosis.

Moderate risk, FDA, Device defect

Octopus 4, Evolution, and Evolution AS Tissue Stabilizer

The Octopus Evolution Tissue Stabilizer has an assembly issue where tubing was incorrectly positioned.

Moderate risk, FDA, Manufacturing problem

Stryker Neurovascular Inzone Detachment System

The INZONE DETACHMENT SYSTEM may experience premature battery drain, causing it to not power on or be unable to detach a coil.

Moderate risk, FDA, Device defect

2 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

2 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

6 recalls

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

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

4 recalls

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

1 recall

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

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

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

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