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.
26,155 detailed records are currently available in this category.
Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled…
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
There is a potential for a loss of package integrity that may compromise the sterility of the product.
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required…
There is a potential for a loss of package integrity that may compromise the sterility of the product.
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge…
There is a potential for a loss of package integrity that may compromise the sterility of the product.
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required…
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.
