Fresenius Medical Care CombiSet Hemodialysis Blood Tubing Sets
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Fresenius Medical Care Renal Therapies Group, LLC, of Waltham, Massachusetts, began the recall on July 29, 2026, for the CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Model Number 03-2522-1. The recall is a communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
The product was distributed nationwide. The FDA added the recall to its Enforcement Report and classified it on September 18, 2026, and included it in the weekly enforcement report on September 30, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
03-2522-1
- UDI-DI
- 00840861102402
- 10840861102409
- Lot
- 26AR01010
- 26BR01072
- 26CR01067
- 26DR01160
- 26DR01198
- 26AR01011
- 26BR01074
- 26CR01069
- 26DR01161
- 26DR01203
- 26AR01034
- 26BR01076
- 26CR01070
- 26DR01162
- 26DR01206
- 26AR01035
- 26BR01077
- 26CR01072
- 26DR01163
- 26DR01207
- 26AR01046
- 26BR01078
- 26CR01073
- 26DR01165
- 26DR01209
- 26AR01047
- 26BR01079
- 26CR01074
- 26DR01166
- 26DR01210
- 26AR01056
- 26BR01082
- 26CR01075
- 26DR01167
- 26DR01255
- 26AR01057
- 26BR01083
- 26CR01076
- 26DR01168
- 26ER01022
- 26AR01058
- 26BR01084
- 26CR01079
- 26DR01170
- 26ER01023
- 26AR01059
- 26BR01085
- 26CR01080
- 26DR01171
- 26ER01024
- 26AR01230
- 26BR01087
- 26CR01081
- 26DR01172
- 26ER01029
- 26BR01007
- 26BR01088
- 26CR01082
- 26DR01173
- 26ER01034
- 26BR01035
- 26BR01210
- 26CR01083
- 26DR01174
- 26ER01035
- 26BR01036
- 26CR01014
- 26CR01084
- 26DR01175
- 26ER01037
- 26BR01037
- 26CR01045
- 26CR01085
- 26DR01177
- 26ER01039
- 26BR01039
- 26CR01046
- 26CR01086
- 26DR01180
- 26ER01040
- 26BR01045
- 26CR01047
- 26CR01087
- 26DR01182
- 26ER01042
- 26BR01049
- 26CR01048
- 26CR01088
- 26DR01183
- 26ER01044
- 26BR01051
- 26CR01049
- 26CR01090
- 26DR01184
- 26ER01048
- 26BR01052
- 26CR01051
- 26CR01091
- 26DR01185
- 26ER01049
- 26BR01053
- 26CR01052
- 26CR01092
- 26DR01186
- 26ER01054
- 26BR01057
- 26CR01054
- 26CR01093
- 26DR01187
- 26ER01055
- 26BR01058
- 26CR01056
- 26CR01094
- 26DR01188
- 26ER01056
- 26BR01059
- 26CR01057
- 26CR01206
- 26DR01189
- 26ER01062
- 26BR01060
- 26CR01058
- 26CR01207
- 26DR01190
- 26ER01065
- 26BR01063
- 26CR01059
- 26CR01208
- 26DR01191
- 26ER01066
- 26BR01064
- 26CR01060
- 26CR01209
- 26DR01193
- 26ER01074
- 26BR01065
- 26CR01061
- 26CR01210
- 26DR01194
- 26ER01266
- 26BR01066
- 26CR01064
- 26DR01013
- 26DR01195
- 26ER01268
- 26BR01067
- 26CR01065
- 26DR01158
- 26DR01196
- 26ER01282
- 26BR01069
- 26CR01066
- 26DR01159
- 26DR01197
Details
- Company began the recall
- Sold in
Domestic: Nationwide Distribution;
- Event ID
- 99700
- Recall No.
- Z-3225-2026
- Company
- Fresenius Medical Care Renal Therapies Group, LLCWaltham, Massachusetts
- Hazard
- Device defect
- Quantity recalled
- 1743026 units
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
All recalls from Fresenius Medical Care Renal Therapies Group, LLC
