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352 reported ongoing
354 records in this archive. Latest source date Aug 6, 2026.
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.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Class IIReported ongoing
Distribution: Worldwide Distribution
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Class IIReported ongoing
Distribution: Worldwide Distribution
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Class IIReported ongoing
Distribution: Worldwide Distribution
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged pr...
Class IIIReported ongoing
Distribution: Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Product may be mislabeled.
Class IIReported ongoing
Distribution: US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Product may be mislabeled.
Class IIReported ongoing
Distribution: US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Pouch seals may be open, compromising sterility.
Class IIReported ongoing
Distribution: Distribution in the US and territories, Japan, and Canada
Pouch seals may be open, compromising sterility.
Class IIReported ongoing
Distribution: Distribution in the US and territories, Japan, and Canada
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain,...
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain,...
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain,...
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain,...
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following imp...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following imp...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 354 records, including 352 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.