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Fresenius Medical Care Holdings, Inc. recalls

Every recall we track for Fresenius Medical Care Holdings, Inc. — 117 in all, from 2014–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.

117recalls
222complaints & reports
134injuries reported
7deaths reported

Recalls per year, by danger level

Recalls from Fresenius Medical Care Holdings, Inc. fell by more than half in 2025 (4, down from 23 in 2024). 3% rated “stop using now”.

2017: 0 recalls20172018: 0 recalls20182019: 0 recalls20192020: 37 recalls — 7 use caution, 29 lower risk, 1 not yet rated3720202021: 20 recalls — 4 use caution, 12 lower risk, 4 not yet rated2020212022: 12 recalls — 2 use caution, 7 lower risk, 3 not yet rated1220222023: 15 recalls — 1 stop using now, 2 use caution, 8 lower risk, 4 not yet rated1520232024: 23 recalls — 14 use caution, 4 lower risk, 5 not yet rated2320242025: 4 recalls — 1 stop using now, 2 use caution, 1 lower risk420252026 (to date): 5 recalls — 1 stop using now, 2 use caution, 2 lower risk52026to date

All FDA recall records for Fresenius Medical Care Holdings, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Fresenius Medical Care Holdings, Inc., by danger level
YearStop using nowUse cautionLower riskNot yet ratedTotal
201700000
201800000
201900000
20200729137
20210412420
2022027312
2023128415
20240144523
202512104
2026 (to date)12205

Fresenius Medical Care Holdings, Inc. recalls before 2017

Recalls on record by year.

  • 20141

Most common reasons for Fresenius Medical Care Holdings, Inc. recalls

  • Exposed to freezing temperatures due to refrigerated truck malfunctions9
  • Potential PCBA leaching from tubing of hemodialysis machines.8
  • Temperature Abuse: Product exposed to temperature outside specified limits.8
  • The peroxide cross-linked tubing has leachables identified as NDL PCBAs.5
  • There is a potential for blood backfill leakage and foreign material.3

What to do if you have a recalled Fresenius Medical Care Holdings, Inc. product

  1. Match the model, catalog or lot number on your device to the recall.
  2. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
  3. Report problems to FDA MedWatch.

See this week’s new recalls.

All Fresenius Medical Care Holdings, Inc. recalls

45 shown

Fresenius Medical Care Holdings, Inc. recall questions

How many recalls has Fresenius Medical Care Holdings, Inc. had?

117 recalls from Fresenius Medical Care Holdings, Inc. are on record with U.S. safety agencies, from 2014–2026 (99 medical device, 18 drug).

What is the most recent Fresenius Medical Care Holdings, Inc. recall?

Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;, dated May 12, 2026. Every Fresenius Medical Care Holdings, Inc. recall is listed on this page, newest first.

Why are Fresenius Medical Care Holdings, Inc. products recalled?

The most common reasons on record: Exposed to freezing temperatures due to refrigerated truck malfunctions (9); Potential PCBA leaching from tubing of hemodialysis machines. (8); Temperature Abuse: Product exposed to temperature outside specified limits. (8); The peroxide cross-linked tubing has leachables identified as NDL PCBAs. (5).

What should I do if I have a recalled Fresenius Medical Care Holdings, Inc. product?

Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.

How do I get alerts for new Fresenius Medical Care Holdings, Inc. recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.