🏥 Medical Devices Class I - Dangerous
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
All Recalls
95,025 total recalls in our database
BF-MP160F: EVIS EXERA Bronchofibervideoscope
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
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular
🏥 Medical Devices Class I - Dangerous
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
HemosIL ReadiPlasTin, Part No. 0020301400
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Woodside Acquisitions
🏥 Medical Devices Class I - Dangerous
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
ACS Cath Lab Pack
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
🏥 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.