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240 reported ongoing
258 records in this archive. Latest source date Sep 3, 2026. 4 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.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Lack of assurance of sterility: bags have the potential to leak..
Class IIReported terminated
Distribution: Nationwide in the USA
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class IIReported terminated
Distribution: Nationwide in the USA
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
Class IIReported ongoing
Distribution: US Nationwide
Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
Class IIReported ongoing
Distribution: US Nationwide
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administra...
Class IReported ongoing
Distribution: Distribution US nationwide, Canada and Germany.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body s...
Class IReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution to Canada.
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body s...
Class IReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution to Canada.
The sterile blister packaging may be damaged, and sterility may be compromised
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of VA.
The sterile blister packaging may be damaged, and sterility may be compromised
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of VA.
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Class IIIReported terminated
Distribution: United States
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 258 records, including 240 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.