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.
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 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…
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…
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 concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur…
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
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…
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
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.
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…
Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Incorrect product and/or label. Sizing is labeled incorrectly.
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.
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,…
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,…
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…
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
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…
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…
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…
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…
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.
