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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.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: US Nationwide , Alaska, and Puerto Rico.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: US Nationwide , Alaska, and Puerto Rico.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: US Nationwide , Alaska, and Puerto Rico.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: US Nationwide , Alaska, and Puerto Rico.
Potential for the Cassette Loading Lever to break.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Emphasizing instructions for LVP duration programming located in the IFU.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Class IReported ongoing
Distribution: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Out-of-specification endotoxin results
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class IReported ongoing
Distribution: Nationwide within the United States as well as AK, HI, and PR.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Class IReported ongoing
Distribution: US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Class IIReported ongoing
Distribution: US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of Minnesota.
Potential for external cassette leaks
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Potential for external cassette leaks
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Potential for external cassette leaks
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Potential for external cassette leaks
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Class IReported ongoing
Distribution: US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at t...
Class IReported ongoing
Distribution: US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Class IReported ongoing
Distribution: US distribution to states of: ID, MN, NV, TX, VA, WI.
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Class IReported ongoing
Distribution: US Nationwide.
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.