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.
29,496 detailed records are currently available in this category.
Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was…
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an…
Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper…
Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into…
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
The wrist straps used for positioning the patient are too long
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as…
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL…
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver…
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the 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.
