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.
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery,…
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic…
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate…
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1,…
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an…
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac…
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during…
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
There is the potential that during implant deployment, the device may not properly deliver a implant.
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an…
Product may be mislabeled.
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.
