--- title: "Fresenius Medical Care Holdings, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Fresenius Medical Care Holdings, Inc. 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-holdings-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Fresenius Medical Care Holdings, Inc. recall records **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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 12, 2026 FDA device enforcement ### [Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;](https://isitonrecall.com/recall/fda-device-z-2321-2026-bicarby-dialysate-model-numbers-rfp-400-g-rfp-401-g-rfp-402-g-rfp-404-g-rfp-407-g-and-rfp-456-g/) 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 II Reported ongoing Distribution: US Nationwide distribution in the states of NY, TN and TX. [Official source for Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2321-2026%22) May 11, 2026 FDA device enforcement ### [5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X ...](https://isitonrecall.com/recall/fda-device-z-2702-2026-5008x-blood-tubing-set-24-units-per-case-includes-the-below-model-numbers-and-descriptions-1-5008x-h/) 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 II Reported 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. [Official source for 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2702-2026%22) May 7, 2026 FDA device enforcement ### [Bicarby Dialysate; Model number: RFP-400-G;](https://isitonrecall.com/recall/fda-device-z-2401-2026-bicarby-dialysate-model-number-rfp-400-g/) 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 II Reported ongoing Distribution: Domestic: TX. [Official source for Bicarby Dialysate; Model number: RFP-400-G;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2401-2026%22) Apr 6, 2026 FDA drug enforcement ### [DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius ...](https://isitonrecall.com/recall/fda-drug-d-0512-2026-delflex-dextrose-peritoneal-dialysis-solution-with-attached-stay-safe-exchange-set-for-intraperitone/) Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperi...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0512-2026%22) Apr 6, 2026 FDA drug enforcement ### [DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius ...](https://isitonrecall.com/recall/fda-drug-d-0513-2026-delflex-dextrose-peritoneal-dialysis-solution-with-attached-stay-safe-exchange-set-for-intraperitone/) Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperi...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0513-2026%22) Oct 25, 2025 FDA device enforcement ### [5008X CAREsystem +CLiC +CDX;](https://isitonrecall.com/recall/fda-device-z-0936-2026-5008x-caresystem-clic-cdx/) 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 II Reported ongoing Distribution: Domestic: LA, MA, MN; [Official source for 5008X CAREsystem +CLiC +CDX;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0936-2026%22) Aug 29, 2025 FDA device enforcement ### [Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NR...](https://isitonrecall.com/recall/fda-device-z-0041-2026-optiflux-high-flux-e-beam-dialyzer-model-numbers-1-0500316e-optiflux-f160nre-12-cs-1-5sa-ebeam-2-050/) 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 II Reported ongoing Distribution: US Nationwide distribution. [Official source for Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEA...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0041-2026%22) May 27, 2025 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10](https://isitonrecall.com/recall/fda-drug-d-0490-2025-0-9-sodium-chloride-injection-usp-flexible-plastic-container-rx-only-fresenius-medical-care-north-am/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: Nationwide. [Official source for 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care N...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0490-2025%22) Apr 29, 2025 FDA device enforcement ### [5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline ...](https://isitonrecall.com/recall/fda-device-z-1992-2025-5008x-hdf-hemodialysis-blood-tubing-set-24-units-per-case-with-the-following-models-a-5008x-standard/) 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 II Reported ongoing Distribution: US Nationwide distribution in the state of Massachusetts. [Official source for 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1992-2025%22) Dec 5, 2024 FDA device enforcement ### [Dialyzer Optiflux 160NRe](https://isitonrecall.com/recall/fda-device-z-0801-2025-dialyzer-optiflux-160nre/) Potential for internal blood leaks due to cracked polyurethane Class II Reported ongoing Distribution: Nationwide Distribution. [Official source for Dialyzer Optiflux 160NRe](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0801-2025%22) Aug 8, 2024 FDA device enforcement ### [Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190...](https://isitonrecall.com/recall/fda-device-z-3124-2024-blood-pressure-module-bpm3-tm-2917b-spare-part-numbers-191378-or-191389-with-firmware-version-s005-i/) 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 II Reported ongoing Distribution: US Nationwide. Canada. [Official source for Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3124-2024%22) Jun 18, 2024 FDA drug enforcement ### [DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container S...](https://isitonrecall.com/recall/fda-drug-d-0608-2024-delflex-peritoneal-dialysis-solution-with-low-magnesium-low-calcium-4-25-dextrose-and-attached-stay/) This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. Class II Reported ongoing Distribution: Nationwide [Official source for DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0608-2024%22) Jun 3, 2024 FDA device enforcement ### [190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2340-2024-190904-2008k-home-hemodialysis-system-w-bibag-blood-pump-rotor-spare-part-model-number-f40015481-rev/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F4001...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2340-2024%22) Jun 3, 2024 FDA device enforcement ### [190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2341-2024-190828-2008k-home-hemodialysis-system-blood-pump-rotor-spare-part-model-number-f40015481-rev-a/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2341-2024%22) Jun 3, 2024 FDA device enforcement ### [191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2342-2024-191014-2008k-home-hd-system-w-bibag-canada-blood-pump-rotor-spare-part-model-number-f40015481-rev-a/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2342-2024%22) Jun 3, 2024 FDA device enforcement ### [190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2343-2024-190395-2008k-home-machine-short-cab-olc-dp-hp-blood-pump-rotor-spare-part-model-number-f40015481-rev/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F400...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2343-2024%22) Jun 3, 2024 FDA device enforcement ### [RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2344-2024-rtl190395-2008k-home-machine-short-cab-olc-dp-hp-blood-pump-rotor-spare-part-model-number-f40015481/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2344-2024%22) Jun 3, 2024 FDA device enforcement ### [RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2345-2024-rtl190828-2008k-home-hemodialysis-system-blood-pump-rotor-spare-part-model-number-f40015481-rev-a/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2345-2024%22) Jun 3, 2024 FDA device enforcement ### [RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2346-2024-rtl190904-2008k-home-hemodialysis-system-w-bibag-blood-pump-rotor-spare-part-model-number-f40015481/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2346-2024%22) Jun 3, 2024 FDA device enforcement ### [RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A](https://isitonrecall.com/recall/fda-device-z-2347-2024-rtlr190395-2008k-home-machine-short-cab-olc-dp-hp-blood-pump-rotor-spare-part-model-number-f40015481/) 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 II Reported ongoing Distribution: Domestic: Nationwide Distribution. International: Canada. [Official source for RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2347-2024%22) ## Reasons in these listed records - 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 product for use for... - 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. - 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 GTIN labeling is used... - Lack of Assurance of Sterility: Potential leaks from perforations in bags. These examples come from this result page and are not a ranking of every recall reason. ## Checking Fresenius Medical Care Holdings, Inc. ### Is there a recall on fresenius medical care holdings, inc. right now? 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. ### 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 Holdings, Inc.](https://isitonrecall.com/check/?q=Fresenius%20Medical%20Care%20Holdings%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)