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57 reported ongoing
60 records in this archive. Latest source date May 12, 2026.
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.
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of NY, TN and TX.
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect G...
Class IIReported ongoing
Distribution: Domestic: TX.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class IIReported ongoing
Distribution: Nationwide in the USA
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class IIReported ongoing
Distribution: Nationwide in the USA
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Class IIReported ongoing
Distribution: Domestic: LA, MA, MN;
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: Nationwide.
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of Massachusetts.
Potential for internal blood leaks due to cracked polyurethane
Class IIReported ongoing
Distribution: Nationwide Distribution.
Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
Class IIReported ongoing
Distribution: US Nationwide. Canada.
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class IIReported ongoing
Distribution: Nationwide
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution. International: Canada.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 60 records, including 57 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.