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9 reported ongoing
18 records in this archive. Latest source date Jan 15, 2026. 3 published notices do not supply a closure status.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Internal testing determined that some sensors may provide incorrect low glucose readings.
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class IReported ongoing
Distribution: Worldwide
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class IReported ongoing
Distribution: Worldwide
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class IReported ongoing
Distribution: Worldwide
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class IReported ongoing
Distribution: Worldwide
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class IReported ongoing
Distribution: Worldwide
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Sensors may provide incorrect high glucose readings
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.
Class IIReported ongoing
Distribution: US, Taiwan, and Colombia
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
Class IIReported terminated
Distribution: US Nationwide distribution.
Incorrect product labeling.
Class IIReported terminated
Distribution: US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, ...
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, ...
Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport.
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Instructions for use were updated.
Class IIReported terminated
Distribution: OUS distribution only
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 18 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.