Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
All Recalls
92,900 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Microbiologics
🏥 Medical Devices Class I - Dangerous
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Microbiologics
🏥 Medical Devices Class I - Dangerous
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
🏥 Medical Devices Class I - Dangerous
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
🏥 Medical Devices Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Stryker
🏥 Medical Devices Class I - Dangerous
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
🏥 Medical Devices Class I - Dangerous
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
🏥 Medical Devices Class I - Dangerous
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
🏥 Medical Devices Class I - Dangerous
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Murata Vios
🏥 Medical Devices Class I - Dangerous
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
🏥 Medical Devices Class I - Dangerous
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
🏥 Medical Devices Class I - Dangerous
Device reaching End of Service prematurely.
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
HF Acquisition Co
🏥 Medical Devices Class I - Dangerous
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
🏥 Medical Devices Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Getinge Usa Sales
🏥 Medical Devices Class I - Dangerous
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.