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.
25,099 detailed records are currently available in this category.
There is potential for the plastic optical tip to become detached from the metal shaft.
A manufacturing error resulted in out of specification R3 Acetabular Shells
There is potential for the plastic optical tip to become detached from the metal shaft.
Distributed to the field without having completed design history files or design transfer activities
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as…
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent…
A manufacturing error resulted in out of specification R3 Acetabular Shells
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use…
False positive results due to potential contamination of reagent.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
A manufacturing error resulted in out of specification R3 Acetabular Shells
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
There is potential for the plastic optical tip to become detached from the metal shaft.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Distributed to the field without having completed design history files or design transfer activities
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.
