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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.
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Pending
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Pending
Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
Class IIReported ongoing
Distribution: Domestic distribution nationwide.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.