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.
22,877 detailed records are currently available in this category.
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result…
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not…
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results,…
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are…
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Patient support table floor plate may be incorrectly installed.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included…
Patient support table floor plate may be incorrectly installed.
Patient support table floor plate may be incorrectly installed.
Patient support table floor plate may be incorrectly installed.
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Patient support table floor plate may be incorrectly installed.
Patient support table floor plate may be incorrectly installed.
The failure to detect the partial obstruction in a 2.5mm sensor.
Patient support table floor plate may be incorrectly installed.
The failure to detect the partial obstruction in a 2.5mm sensor.
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated…
Patient support table floor plate may be incorrectly installed.
Patient support table floor plate may be incorrectly installed.
Patient support table floor plate may be incorrectly installed.
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.
