Agency classClass IIOur severity:Severe FDA (Devices)·Z-0186-2014·Announced 2013-11-20

Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

Fresenius Medical Care is recalling 508,029 cases of Combiset Blood Lines for hemodialysis because connections may disconnect if not tightened correctly, leading to blood loss.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device where failure can lead to blood loss, a significant injury risk, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 508,029 cases of Combiset Blood Lines (Catalog Number: 03-2622-3) intended for use as the extracorporeal blood circuit during hemodialysis. The product is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. The recall covers all lot codes and includes distribution in the United States (nationwide) and Canada.

The recall was initiated because updated instructions for use indicate that bloodline connections not tightened per the operator's manual may disconnect, which can lead to blood loss. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities using this product should stop using the affected blood lines and contact Fresenius Medical Care for further instructions on how to proceed with the recall and replacement of the product.

The recalled product

Product: Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Hemodialysis Equipment
Hazard: blood-loss
device-failure
Affected units: 508,029

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lot codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

See all →

Moderate
5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
High
Bicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
High
Bicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
Severe
DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
High
DELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13

Same hazard · blood loss