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44 reported ongoing
52 records in this archive. Latest source date Aug 10, 2026. 1 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.
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
Class IReported ongoing
Distribution: US Distribution to states of: CO, ID, NJ, UT.
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Class IReported ongoing
Distribution: US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to se...
Class IReported ongoing
Distribution: US distribution to states of: CA, CO, NJ, UT, and WI.
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annu...
Class IIReported completed
Distribution: US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Class IReported ongoing
Distribution: Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class IIReported terminated
Distribution: Nationwide in the USA
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class IIReported terminated
Distribution: Nationwide in the USA
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class IIReported terminated
Distribution: Nationwide in the USA
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to ...
Class IIReported completed
Distribution: US Nationwide distribution in the states of WI and NJ.
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or resp...
Class IReported terminated
Distribution: Domestic distribution to NJ and WI.
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of NJ, WI.
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class IReported terminated
Distribution: Nationwide USA
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 52 records, including 44 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.