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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. Source coverage and dates.

Records and reported status

FDA device enforcement

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

Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water sup...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AL, IN, AK, WI.

Official source
FDA device enforcement

Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorpo...

Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source
FDA device enforcement

Stay Safe Cap

Updating the labeling to include additional warnings and contraindications for potential side effects.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source

Reasons in these listed records

  • Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
  • 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.
  • Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
  • The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

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.

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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.

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 and the agency's current notices.

Where can I find older records?

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.

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