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.
24,239 detailed records are currently available in this category.
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent,…
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal,…
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the…
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Patient chart label contains incorrect Part Number and volume amount.
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
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.
