Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUS...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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.
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.
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.
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Allia IGS 7 Pulse 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.
Allia IGS Pulse 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.
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPO...
Due to incorrect incubation process being performed on product.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUL...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Plum Duo Precision IV Pump, 40002-0403
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: 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 with ENFit ...
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 with ENFit ...
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 with ENFit ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007...
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
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.
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
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.
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27,...
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, ...
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
Allia IGS 5 Pulse 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.
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.
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog N...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.