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.
28,535 detailed records are currently available in this category.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a…
Potential sterility deficiency.
The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Sterility compromised due to breach in sterile packaging
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose…
Sterility of device may be compromised due to sterile package breakage.
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components…
The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item)…
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other…
Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.
Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue…
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.
A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated
Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other…
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
A diode was inadvertently not assembled into the system, which may result in coil overheating
Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is…
In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the…
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.
