🏥 Medical Devices Class I - Dangerous
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
All Recalls
95,018 total recalls in our database
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
Avanos Medical
🏥 Medical Devices Class I - Dangerous
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
🏥 Medical Devices Class I - Dangerous
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. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
Allia IGS Pulse angiographic X-ray system
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
🏥 Medical Devices Class I - Dangerous
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Halyard, Pain Pack. Kit Code: AMPK48-01.
AVID Medical
🏥 Medical Devices Class I - Dangerous
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Allia Moveo angiographic X-ray system
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
Due to incorrect incubation process being performed on product.
🏥 Medical Devices Class I - Dangerous
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
🏥 Medical Devices Class I - Dangerous
Reusable electrodes may not meet expected performance levels.
🏥 Medical Devices Class I - Dangerous
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Allia IGS 5 Pulse angiographic X-ray system
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
Due to incorrect incubation process being performed on product.
🏥 Medical Devices Class I - Dangerous
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: 30-4320
Avanos Medical
🏥 Medical Devices Class I - Dangerous
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
🏥 Medical Devices Class I - Dangerous
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
ICU Medical
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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 Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Avanos Medical
🏥 Medical Devices Class I - Dangerous
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.