PlainRecalls

Fresenius Medical Care Holdings, Inc.

Compiled from official public sources by the publisher.

166 recalls on record · Latest: Jul 15, 2026

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Agency notice ledger

Federal filing book Fresenius Medical Care Hold… HEAVY-BOOK · MULTI-AGENCY

#94 of 14,151 · 166 notices · 0.159% archive

  • BOOK 166 notices
  • RANK #94 of 14,151
  • SHARE 0.159% archive
  • AGENCY FDA Devices (148)
  • CAT medical devices
  • CATS 3 categories
  • LATEST Jul 15, 2026
  • PHOTO Ford,Lincoln

Nearest notice-volume peer: Ford,Lincoln (1 notice gap)

Fresenius Medical Care Holdings, Inc. accounts for about 0.159% of the 104,423-notice archive on 166 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Fresenius Medical Care Hold… compares to 14,151 recalling firms

Fresenius Medical Care Holdings, Inc. ranks 94th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Fresenius Medical Care Hold… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

166 94th of 14151 higher than 14,057 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Fresenius Medical Care Hold… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Fresenius Medical Care Holdings, Inc. holds about 0.159% of archive notices alongside 166 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026

How the 166 notices break down

Same federal filing book as the hero total — split by issuing agency, no new counts.

FDA Devices Moderate Jul 15, 2026

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 HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
FDA Devices Moderate Jun 17, 2026

Bicarby Dialysate; Model number: RFP-400-G;
FDA Devices Moderate Jun 17, 2026

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
FDA Drug Moderate May 13, 2026

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 Medical Care North America, 920 Winter Street, Waltham, MA 02451.
FDA Drug Moderate May 13, 2026

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 Medical Care North America, 920 Winter Street, Waltham, MA 02451.
FDA Devices Moderate Dec 24, 2025

5008X CAREsystem +CLiC +CDX;
FDA Devices Moderate Oct 15, 2025

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 F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
FDA Drug Moderate Jul 2, 2025

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
FDA Devices Moderate Jun 25, 2025

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 w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.
FDA Devices Moderate Jan 15, 2025

Dialyzer Optiflux 160NRe
FDA Devices Moderate Sep 18, 2024

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, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Drug Moderate Jul 24, 2024

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 Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
FDA Devices Moderate Jul 17, 2024

RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024

RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024

190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024

190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024

190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024

RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024

191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jul 17, 2024

RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Devices Moderate Jun 19, 2024

US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
FDA Devices Moderate May 29, 2024

Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Devices Moderate May 22, 2024

Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
FDA Devices Critical Apr 3, 2024

stay-safe /Luer Lock Adapter 4 in
FDA Devices Critical Apr 3, 2024

stay-safe /Luer Lock Catheter Ext. 18 in
FDA Devices Critical Apr 3, 2024

stay-safe /Luer Catheter Ext. 6 in
FDA Devices Critical Apr 3, 2024

stay-safe /Luer Lock Catheter Ext. 12 in
FDA Devices Critical Apr 3, 2024

stay-safe /Safe Lock Catheter Ext. 12 in
FDA Drug Moderate Jan 10, 2024

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
FDA Devices Low Jan 3, 2024

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
FDA Devices Moderate Dec 13, 2023

Stay Safe Cap
FDA Devices Critical Oct 18, 2023

2008T HD SYS. W/O CDX BLUESTAR
FDA Devices Critical Oct 18, 2023

2008T Hemodialysis SYS, with CDX
FDA Devices Critical Oct 18, 2023

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
FDA Devices Critical Oct 18, 2023

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Devices Critical Oct 18, 2023

2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
FDA Devices Critical Oct 18, 2023

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
FDA Devices Critical Oct 18, 2023

2008T Hemodialysis System w/Bibag
FDA Devices Critical Oct 18, 2023

2008T GEN 2 Bibag without CDX
FDA Devices Critical Oct 18, 2023

2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Devices Critical Oct 18, 2023

2008T Hemodialysis System without CDX
FDA Devices Critical Oct 18, 2023

2008T HD SYS. CDX BLUESTAR
FDA Drug Moderate Jun 7, 2023

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
FDA Devices Moderate Dec 28, 2022

2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Drug Moderate Dec 14, 2022

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
FDA Devices Moderate Nov 16, 2022

NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

Fresenius Medical Care Hold… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms that share this firm's dominant product category.

Ge Medical Systems, LLC 168 Synthes (USA) Products LLC 164 Stryker Instruments Div. of Stryker Corporation 161 Avid Medical, Inc. 172

Frequently Asked Questions

How many federal recall notices name Fresenius Medical Care Hold…? ▼
PlainRecalls indexes 166 distinct federal recall events naming Fresenius Medical Care Holdings, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Fresenius Medical Care Hold… sit among other recalling firms? ▼
Fresenius Medical Care Holdings, Inc. ranks #94 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Fresenius Medical Care Hold…'s notices? ▼
FDA Devices accounts for 148 of this firm's 166 indexed notices across 2 issuing agencies.
What product category dominates Fresenius Medical Care Hold…'s filing book? ▼
Filings for Fresenius Medical Care Holdings, Inc. span 3 product categories, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Fresenius Medical Care Holdings, Inc.: 166 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Fresenius Medical Care Holdings, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026