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.
28,065 detailed records are currently available in this category.
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a…
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
The Access immunoassays are susceptible to biotin interference.
Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the…
The Access immunoassays are susceptible to biotin interference.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
Cotton tip of the device may disengage due to insufficient adhesive
The incorrect Loctite adhesive was used to assemble the impactor heads.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Linear performance information in product insert does not match that listed in the approved premarket notification
The Access immunoassays are susceptible to biotin interference.
Packaging breach may compromise sterility
Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a…
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista…
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
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.
