--- title: "Fresenius Medical Care Renal Therapies Group, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Fresenius Medical Care Renal Therapies Group, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/fresenius-medical-care-renal-therapies-group-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Fresenius Medical Care Renal Therapies Group, LLC recall records **8** reported ongoing 8 records in this archive. Latest source date Aug 10, 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 10, 2026 FDA device enforcement ### [5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6](https://isitonrecall.com/recall/fda-device-z-3084-2026-5008x-standard-hd-pre-flush-standard-blood-tubing-set-part-number-03-5110-6/) Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania. [Official source for 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3084-2026%22) Aug 10, 2026 FDA device enforcement ### [5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3](https://isitonrecall.com/recall/fda-device-z-3085-2026-5008x-hd-hdf-standard-blood-tubing-set-part-number-03-5300-3/) Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania. [Official source for 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3085-2026%22) Aug 10, 2026 FDA device enforcement ### [5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C](https://isitonrecall.com/recall/fda-device-z-3086-2026-5008x-hd-hdf-with-clic-blood-tubing-set-part-number-03-5300-3c/) Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania. [Official source for 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3086-2026%22) Aug 10, 2026 FDA device enforcement ### [5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8](https://isitonrecall.com/recall/fda-device-z-3087-2026-5008x-hd-hdf-with-twister-blood-tubing-set-part-number-03-5350-8/) Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania. [Official source for 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3087-2026%22) Jul 14, 2026 FDA device enforcement ### [GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis](https://isitonrecall.com/recall/fda-device-z-3091-2026-granuflo-dry-acid-concentrate-product-numbers-0fd2251-3b-0fd3251-3b-dry-acid-concentrate-for-bicarbo/) Complaints of blue-green discoloration in product Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Mexico. [Official source for GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3091-2026%22) Jul 14, 2026 FDA device enforcement ### [NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid...](https://isitonrecall.com/recall/fda-device-z-3092-2026-naturalyte-liquid-acid-concentrate-for-bicarbonate-hemodialysis-product-numbers-08-1251-1-08-2251-0/) Complaints of blue-green discoloration in product Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Mexico. [Official source for NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3092-2026%22) Jul 14, 2026 FDA device enforcement ### [Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis](https://isitonrecall.com/recall/fda-device-z-3093-2026-citrasate-liquid-acid-concentrate-for-bicarbonate-hemodialysis-product-numbers-08-2251-ca-08-3251-ca/) Complaints of blue-green discoloration in product Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Mexico. [Official source for Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3093-2026%22) Jun 30, 2026 FDA device enforcement ### [Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.](https://isitonrecall.com/recall/fda-device-z-3017-2026-fresenius-medical-care-2008t-bluestar-hemodialysis-machine-model-numbers-191126-191130/) Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3017-2026%22) ## Reasons in these listed records - Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. - Complaints of blue-green discoloration in product - Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines. These examples come from this result page and are not a ranking of every recall reason. ## Checking Fresenius Medical Care Renal Therapies Group, LLC ### Is there a recall on fresenius medical care renal therapies group, llc right now? This archive contains 8 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? 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. ### What if the search finds no matching record? 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](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/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. ## Keep checking [Search Fresenius Medical Care Renal Therapies Group, LLC](https://isitonrecall.com/check/?q=Fresenius%20Medical%20Care%20Renal%20Therapies%20Group%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)