Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device
The TD Navio Midi Speech Generating Device may have damaged battery mounting tabs, causing internal short circuit and heating.
2 products
Medical device recalls
Medical device recalls from FDA, newest first.
13 recalls
Kico Knee Innovation Arvis Surgical Navigation System GEN 2
The ARVIS surgical navigation system may show a tilted image due to an internal sensor issue.
Philips Cardiac Workstation 5000 and 7000
The Cardiac Workstation 5000 may provide inaccurate heart rate data.
2 products
Dentsply Sirona Capsule Mixer
The Dentsply Sirona Capsule Mixer can discharge electricity when unplugged.
Intersurgical Guedel Oropharyngeal Airways
One-Piece Guedel Airway devices could potentially be occluded or partially occluded.
2 products
EndoFLIP System
The EndoFLIP System can incorrectly flag catheters as expired, making them unavailable for clinical procedures.
3 recalls
Erbe USA ERBECRYO 2 Cryosurgical Unit
The ERBECRYO 2 Cryosurgical Unit can rupture its cryoprobe due to excessive pressure from a strong pull on the hose.
ProNephro AKI (NGAL) Reagent Kit
The ProNephro AKI (NGAL) Reagent Kit may lead to missed diagnosis of renal disease.
BIOFIRE Respiratory Panel 2.1 (RP2.1)
Reason given by FDA: Due to increase in false negative results.
2 recalls
Waldemar Link Endo-Model Tibial Plateau Replacement Sets
The Endo-Model replacement set for a tibial plateau incorrectly contains a Pure Hinge plateau, which could lead to prolonged surgery or implant wear.
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
The Baxter Duo-Vent Solution Set and Male Luer Lock Adapter can have air bubbles in the drip chamber and tubing.
2 recalls
OBP Medical ER-Spec Single-Use Vaginal Speculum with LED Light Source
The ER-Spec vaginal speculum may have a burr on the blade, introducing a sharp edge for patients and providers.
Terumo Glidesheath Slender A-Kit
The Glidesheath Slender was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
4 recalls
Galt Medical Boston Scientific Enhance Transcarotid/Peripheral Access Kit
The Enhance Transcarotid/Peripheral Access Kit has black depth markings that may detach from the outer sheath.
Xhibit Central Station
The Xhibit Central Station has audio/video failures due to a display port component.
Roche Navify Digital Pathology Software
Reason given by FDA: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window.
BOBBY Balloon Guide Catheter
The BOBBY Balloon Guide Catheter has an increased rate of balloon pinhole defects.
3 recalls
Contego Medical Neuroguard IEP Carotid Stent and Balloon System
The Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System may fail to open its integrated filter.
Instrumentation Laboratory GEM Premier 7000 and GEM Premier 5000 Blood Analyzers
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 and GEM Premier 5000 PAK lots did not meet established manufacturing specifications.
2 products
U2 Total Knee System Femoral Offset Bushings
Femoral offset bushings have incorrect engraved numbering that could cause incorrect implant orientation.
2 products
6 recalls
Medline Hudson RCI Heated Neonatal Breathing Circuits
Neonatal and infant heated wire breathing circuits may experience sporadic failure.
4 products
Siemens Healthcare Diagnostics Atellica CH Urine Albumin
Atellica CH Urine Albumin tests may cause falsely depressed urea nitrogen and hemoglobin A1c results.
Philips Allura and Azurion X-Ray Systems
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
3 products
HardyDisk AST Cefiderocol 30µg (FDC30)
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
United Orthopedic U2 and USTAR II Knee Trial and Instrument Sets
Knee femur prosthesis trials and adaptors may not assemble properly due to an incomplete process of the component screw.
4 products
Boston Scientific Infinion CX Lead Kit
The INFINION CX lead kit may have stress at the anchor site, causing high impedance or lead fractures.
2 recalls
FilmArray NGDS Warrior Panel
The FilmArray NGDS Warrior Panel has mismatches between the outbreak strain and the reference strain used in its development.
Merge OrthoPACS and PACS
Merge PACS may show thumbnails from a previous patient study while another is open.
2 products
5 recalls
Maquet Flow Anesthesia Machines
Events observed where anesthetic agent was not delivered when the vaporizer was activated.
Stryker Ahto Tube Sets and Suction/Irrigator Packaging
Stryker tube sets can leak from the handpiece during use.
5 products
Medical Action Industries Dialysis Change Tray Clear Sequence
The Dialysis Change Tray Clear Sequence has an improper seal that may cause doming or tearing of the silicone seal.
OXOS Medical MC2 Portable X-Ray System
The MC2 Portable X-Ray System has a defective circuit board that overheats.
Innovasis Vector Pedicle Screw System Anti-Torque
The anti-torque instrument may have an undersized condition that could prevent it from engaging with the screw, leading to surgical delay.
4 recalls
THERANICA BIOELECTRONICS Nerivio Infinity
Nerivio Infinity has a potential for a thermal-runway event during charging, resulting in smoke and odor.
FORWARD Oral Airway Kit and Kingfisher Compact Individual First Aid Kit
The FORWARD Oral Airway Kit may have an occluded or partially occluded Guedel Airway tip.
2 products
Quantum Rehab Power Wheelchairs
Quantum Rehab powered wheelchairs may show reminder pop-ups while in use, which can cause an unexpected park brake stop and lead to a fall or injury.
13 productsCharger for the Therabody Theragun, G4 PRO Massage Device
The charger for the Theragun G4 PRO may overheat, posing a fire risk.
1 recall
Bard Access Systems BD Needle Kit for Powered Driver
BD Needle Kit for Powered Driver may have difficulty removing the obturator, potentially delaying therapy and causing serious injury or death.
2 recalls
Stryker Hoffmann II Connecting Rod Micro
Stryker Hoffmann II Connecting Rod Micro may crack following cleaning and sterilization.
7 products
Instrumentation Laboratory GEM Premier 5000 and GEM Premier 7000 Blood Analyzers
GEM Premier 5000 and 7000 systems with BCR wands may assign results to wrong patient.
8 products2 recalls
SeaSpine OsteoBallast and Ballast Bone Grafts
The products were filled with approximately 4.5 cc DBM instead of approximately 7.5 cc DBM.
ResMed Astral 100 and 150 Ventilators
The Resmed Astral ventilator system can fail due to electrolyte leakage, interrupting ventilation therapy.
2 recalls
Philips CT Scanners
The CT scan may not trigger automatically after Bolus Tracking, causing inadequate diagnosis and potential rescan.
3 products
Medtronic EOPA Arterial Cannulas
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass.
6 products
1 recall
Argon Medical Devices L-Cath Catheters
L-Cath PICC S/L Peripherally Inserted Central Catheter may leak or crack at the hub, causing blood loss and infection.
2 products
2 recalls
Medline Convenience Kits Containing Bard Silastic Foley Catheters
Medline convenience kits contain Bard Silastic Foley Catheters with increased raw material on the surface, which may be harmful.
9 products
Medline Hip and Knee Procedure Kits
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
2 products
4 recalls
Medline Convenience Kits
Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
3 productsAVID Medical Halyard Standard Line Insertion Pack
The Halyard STANDARD LINE INSERTION PACK has defective silicone seals that may cause fluid occlusion or leakage.
Emano Flow
The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.