🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
All Recalls
92,900 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Glycar SA Pty.
🏥 Medical Devices Class I - Dangerous
The impacted lot may not meet the required tensile strength specification.
FlexLab (FLX); Version: FLX-217-40;
Inpeco S.A.
🏥 Medical Devices Class I - Dangerous
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
IntelePACS - InteleConnect / TechPortal
INTELERAD MEDICAL SYSTEMS INCORPORATED
🏥 Medical Devices Class I - Dangerous
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
🏥 Medical Devices Class I - Dangerous
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
BioFire Diagnostics
🏥 Medical Devices Class I - Dangerous
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.