Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
25,676 detailed records are currently available in this category.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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…
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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…
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…
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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…
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…
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
The firm received reports of a number of broken latches on the floorsitter.
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
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
