ACS Cath Lab Pack
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
BF-MP60: OES Bronchofiberscope
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
ACS Lap Chole Pack
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
🏥 Medical Devices Class I - Dangerous
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
SIMPLIVIA HEALTHCARE
🏥 Medical Devices Class I - Dangerous
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
🏥 Medical Devices Class I - Dangerous
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
🏥 Medical Devices Class I - Dangerous
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
TMJ Arthroscopy Drape, 85''x 96''
Microtek Medical
🏥 Medical Devices Class I - Dangerous
Latex content in product was labeled incorrectly as latex free.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Diagnostic Kit SARS-cCo V Antigen Rapid Test
USA Medical
🏥 Medical Devices Class I - Dangerous
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare Co.
🏥 Medical Devices Class I - Dangerous
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.