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546 reported ongoing
549 records in this archive. Latest source date Aug 11, 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.
Convenience kits labeled as sterile have not gone through the sterilization process.
Class IReported ongoing
Distribution: US Distribution to States of: FL, MD, NJ, TN
Convenience kits labeled as sterile have not gone through the sterilization process.
Class IReported ongoing
Distribution: US Distribution to States of: FL, MD, NJ, TN
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic...
Class IReported ongoing
Distribution: Domestic US distribution nationwide. International distribution pending. No international distribution.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic...
Class IReported ongoing
Distribution: Domestic US distribution nationwide. International distribution pending. No international distribution.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic...
Class IReported ongoing
Distribution: Domestic US distribution nationwide. International distribution pending. No international distribution.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic...
Class IReported ongoing
Distribution: Domestic US distribution nationwide. International distribution pending. No international distribution.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic...
Class IReported ongoing
Distribution: Domestic US distribution nationwide. International distribution pending. No international distribution.
The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate.
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
The potential for a lack of sterility
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 549 records, including 546 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.