🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
All Recalls
95,025 total recalls in our database
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
🏥 Medical Devices Class I - Dangerous
Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Abbott Laboratories
🏥 Medical Devices Class I - Dangerous
Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
🏥 Medical Devices Class I - Dangerous
When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a component of the LSM 700, 800 and 900 system
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Microbiologics
🏥 Medical Devices Class I - Dangerous
KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
Synvasive Technology
🏥 Medical Devices Class I - Dangerous
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
🏥 Medical Devices Class I - Dangerous
The firm received reports of a number of broken latches on the floorsitter.
🏥 Medical Devices Class I - Dangerous
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
🏥 Medical Devices Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.