Fresenius Bicarbonate Jug Adapter Recalled for Premature Distribution
Fresenius Medical Care is recalling 703 Bicarbonate Jug Adapters distributed before receiving FDA 510(k) approval.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses or injuries, and the hazard is primarily regulatory (distribution prior to approval), fitting the criteria for a moderate severity score.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 703 units of the Bicarbonate Jug Adapter (Part Number 650103) for the 2008 Series Hemodialysis machine. The adapter is a socket that accepts the machine spike to draw concentrate from the container. The recall was initiated because the product was distributed prior to receiving FDA 510(k) approval.
The affected units were distributed nationwide. No specific illnesses, injuries, or adverse events are reported in the source text. Consumers and healthcare facilities should stop using the affected adapters and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 703
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateFresenius Medical Care Recalls Unqualified Hemodialysis Power Supply Assemblies
FDA (Devices) · 2015-02-04
- ModerateFresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
FDA (Devices) · 2026-09-30
- ModerateFresenius Medical Care Recalls Honeywell Pressure Transducers for Hemodialysis Systems
FDA (Devices) · 2020-04-01
- SevereFresenius Citrasate Liquid Acid concentrate drums recalled for low sodium levels
FDA (Devices) · 2021-01-20
- ModerateFresenius 2008 Series Hemodialysis Machines Recalled for False Blood Leak Alarms
FDA (Devices) · 2016-04-13
- SevereFresenius Recalls Naturalyte Liquid Bicarbonate Concentrate Due to Contamination
FDA (Devices) · 2014-05-28