Intuitive Surgical Da Vinci PSS SP1098
The Da Vinci Assy, PSS, SP1098 may have a retainer pin issue that can cause uncontrolled motion.
Medical device recalls
Medical device recalls from FDA, newest first.
3 recalls
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.
4 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.
3 products
HeartMate 3 Left Ventricular Assist System Kits, System Controller, and Backup Battery
Due to 11 volt Backup Battery failures.
3 productsImpella CP Set with SmartAssist
Impella CP Set with SmartAssist can cause low purge pressure alarms and loss of circulatory support.
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.
2 recalls
GE HealthCare Giraffe OmniBed Devices
The Giraffe OmniBed has a potential issue with the canopy soffit that could cause patient injury.
3 products
ConMed AirSeal Access Ports and Obturators
ConMed AirSeal Access Port and Obturator may cause overpressure alerts.
11 products
1 recall
Philips MultiDiagnost Eleva and Allura Xper Systems
Philips MultiDiagnost Eleva and Allura Xper systems have a hand switch button that may not fully release.
2 products
2 recalls
ALYON and HarmonyAIR A-Series Surgical Lighting System
The surgical lighting system has light intensity control buttons that may detach.
2 products
HarmonyAIR A-Series Surgical Lighting System
The HarmonyAIR A-Series Surgical Lighting System has paint that may chip or peel on its light heads.
1 recall
Medline Convenience Kits
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive.
34 products
3 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.
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.
Boston Scientific CSK and TCN Electrodes
Boston Scientific CSK Electrodes may not meet expected performance levels.
2 products
2 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.
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.
2 recalls
Medartis APTUS Cannulated Compression Screws
Cannulated Compression Screws for bone fixation have an off-center cannulation.
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.
6 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.
CGuard Prime Carotid Stent System
The CGuard Prime Carotid Stent System may encounter complications during deployment, causing high resistance or inability to deploy.
6 products
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.
5 products
Fresenius Medical Care Bicarby Dialysate
Bicarby Dialysate can leak during preparation, posing a slip and fall hazard.
Plum Duo Infusion, Duo Precision IV, and Solo Precision IV Pump
The Plum Solo Precision IV Pump may not display a soft limit alert, potentially leading to under- or over-delivery.
3 products
D.O.R.C. TDC VELOCE Two Dimensional Cutters
TDC Veloce cutters have a loose outer knife that can become loose during use.
3 products
4 recalls
Siemens Artis Pheno and Artis Icono Interventional Fluoroscopic X-Ray Systems
These interventional fluoroscopic x-ray systems may show a 0 dose while actually applying x-ray to the patient.
2 products
Draeger Atlan A350 and A350XL Anesthesia Workstations
The Atlan A350 anesthesia workstation indicated a failure of the piston ventilator before use or suffered a failure of mechanical ventilation during use.
2 products
KayserBett IDA Pediatric Care Bed
The pediatric care bed can be operated by a child if not locked, leading to serious injury or death.
Da Vinci 5
The Da Vinci 5 system tower can unintentionally activate its near infrared handheld camera when turning off illumination.
4 recalls
Aligned Medical Fluids Kit
The Aligned Medical AMS16835 Fluids Kit RX contains lidocaine hydrochloride injection with quality issues.
CareFusion 303 BD Pyxis Medication Cabinets
BD Pyxis medication cabinets have a fingerprint scanner that may overheat and cause first-degree burns.
8 products
Bayer Avanta Multi-Patient Administration Tube Sets
Avanta Multi-Patient Administration Tube Sets have a fit issue with the valve interface, causing unstable connection.
B. Braun Spinal Needle Procedure Kits
Spinal Needle procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP, with potential quality issues.
3 products
2 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.
2 products
Shimadzu Digital Angiography and Radiography Systems
Digital Angiography Systems and a Digital Radiography System have electromagnetic contactors that may weld together.
2 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.
Neptune Smart Docking Station
The Neptune Smart Docking Station may not have completed required testing and poses a risk of electrical shock.
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.
B. Braun Anesthesia and Catheter Trays
The Cesk Northside Anesthesia Tray has a potential cracking of the butyrate tubing, rendering it unusable.
8 productsExacta Mix Vented Micro-Volume Inlet
Exacta Mix Vented Micro-Volume Inlet tubing sets may contain incorrect filters, causing reduced flow and clinical effects.
Becton Dickinson & Company BD Spinal Trays
BD Spinal Trays with Quincke or Whitacre needles have quality deficiencies related to acceptance testing.
10 products
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.
3 recalls
GE HealthCare Carescape Telemetry Server
GE HealthCare CARESCAPE Telemetry Server can have a persistent NO COMM or OFF NETWORK condition, potentially causing loss of ECG and SpO2 monitoring.
6 products
Medline Anesthesia and Spinal Trays
Medline kits containing Huons Bupivacaine in Dextrose Injection have quality issues, including data integrity concerns and efficacy complaints.
7 products
Philips Azurion and Allura Systems
The Azurion system may show decreased performance as it ages, potentially causing loss of imaging functionality.
2 products
2 recalls
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.
3 products
Dexcom G7 Continuous Glucose Monitoring System
Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used.
1 recall
Automated Impella Controller (AIC)
The Automated Impella Controller may interrupt motor control, have startup issues, or boot up improperly.
3 recalls
Philips Azurion Systems
Philips Azurion systems may have table movements impacted due to mechanical wear of the Float Tabletop control.
Philips Azurion, Allura and Integris-Allura Systems
The Azurion system's deaeration hose may degrade, potentially causing oil leakage that affects cooling performance.
3 products