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.
23,781 detailed records are currently available in this category.
Potential for the incorrect size stent-graft than the printed carton label.
QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result…
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained…
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could…
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained…
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by…
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained…
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other…
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained…
QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result…
The custom procedure packs contain light handle covers that have been recalled by another firm.
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor…
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal…
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained…
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could…
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could…
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by…
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in…
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement…
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.
