Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acut...
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Plum Duo Infusion Pump, 40002-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-1...
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0....
Reusable electrodes may not meet expected performance levels.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUL...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 3...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23,...
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Num...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannu...
The cannulation of the CCS screw is not centered.
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ...
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Allia Moveo angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, So...
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Temperature probe devices lack FDA clearance.
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: L...
Potential for the Cassette Loading Lever to break.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL,...
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.