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.
26,628 detailed records are currently available in this category.
The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version 4.2 was…
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides…
The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When printing…
The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been…
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for…
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.
