MedicaLyte Liquid Bicarbonate Concentrate Recalled for High Endotoxin Levels
Nipro Renal Solutions is recalling MedicaLyte Liquid Bicarbonate Concentrate due to high endotoxin levels. The product is used in hemodialysis.
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 high endotoxin levels in hemodialysis concentrates, which poses a significant risk of serious injury or death, meeting the criteria for a Severe rating.
Plain-English summary
Nipro Renal Solutions USA, Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate (REF: BC-100 and BC+201) because the hemodialysis concentrates contain high endotoxin levels. The recall involves 3,286 cases of the product.
The affected lots are BC-100 Lot N4L022 (exp. 11/13/2026), BC-100 Lot N4L037 (exp. 11/18/2026), and BC+201 Lot N4L010 (exp. 11/06/2026). The product was distributed worldwide, including nationwide in the US states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, and PA, as well as in Guatemala and Panama.
This is an FDA Class II recall. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- Manufacturer
- Nipro Renal Soultions USA, Corporation
- Affected units
- 3,286
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 (2)
- BC-100 - Lot:N4L022 (exp.11/13/2026)
- N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
Distribution
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