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.
27,110 detailed records are currently available in this category.
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of…
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
There is a possibility of low volume and/or leaking standard bottles.
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he…
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the…
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Potential friction holes may affect the sterility of the product.
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor…
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.
