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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.
Product may be mislabeled with an incorrect lid stock label.
Class IIReported ongoing
Distribution: US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
Lack of assurance of sterility: bags have the potential to leak.
Class IIReported terminated
Distribution: USA Nationwide
Kits were assembled with the incorrect Filter Straw.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Kits were assembled with the incorrect Filter Straw.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Subpotent: Low anti-factor IIa Potency.
Class IIReported terminated
Distribution: Nationwide in the USA
Subpotent Drug: low Anti-Factor IIa potency.
Class IIReported terminated
Distribution: Nationwide in the USA
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks...
Class IIReported completed
Distribution: USA Nationwide.
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks...
Class IIReported completed
Distribution: USA Nationwide.
Lack of sterility assurance: Bags have the potential to leak.
Class IIReported terminated
Distribution: FL, NJ, PA
The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both pat...
Class IIReported ongoing
Distribution: Distribution US nationwide, Canada and Saudi Arabia.
The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both pat...
Class IIReported ongoing
Distribution: Distribution US nationwide, Canada and Saudi Arabia.
The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expos...
Class IIReported ongoing
Distribution: Distribution US nationwide, Canada and Saudi Arabia.
Potential for leakage at the catheter hub.
Class IIReported ongoing
Distribution: Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
Lack of sterility assurance: leaking bags
Class IIReported terminated
Distribution: USA Nationwide
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
Class IIReported terminated
Distribution: US Distribution to states of: MA, VT
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace ...
Class IIReported terminated
Distribution: US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis mach...
Class IIReported terminated
Distribution: US Nationwide distribution.
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis mach...
Class IIReported terminated
Distribution: US Nationwide distribution.
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.