ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
All Recalls
95,089 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
🏥 Medical Devices Class I - Dangerous
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
🏥 Medical Devices Class I - Dangerous
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
🏥 Medical Devices Class I - Dangerous
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
🏥 Medical Devices Class I - Dangerous
Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.
LAUREATE World Phaco System
Alcon Research
🏥 Medical Devices Class I - Dangerous
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
🏥 Medical Devices Class I - Dangerous
Belt clip may become detached causing electronic components to be exposed.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
🏥 Medical Devices Class I - Dangerous
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
🏥 Medical Devices Class I - Dangerous
There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected. The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.
🏥 Medical Devices Class I - Dangerous
Elevated levels of invalid results.
Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
Allergy Laboratories
🏥 Medical Devices Class I - Dangerous
Potential for glass particles within the vials
Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.