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.
24,725 detailed records are currently available in this category.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample…
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained…
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port…
Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
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.
