DeviceSignal · Recall classified
Nipro Renal Soultions USA, Corporation
FDA classified a device recall on 2026-09-10 · Class II · Z-3134-2026
EventRecall classified
Effective2026-09-10
ClassificationClass II
On 2026-09-10 the FDA classified a device recall from Nipro Renal Soultions USA, Corporation as Class II. Product: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)). Recall Z-3134-2026. The firm initiated it on 2026-08-05. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3134-2026
- Classification
- Class II
- Classified on
- 2026-09-10
- Initiated on
- 2026-08-05
- Firm
- Nipro Renal Soultions USA, Corporation
- Reason
- Hemodialysis concentrates contain high endotoxin levels
- Product
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3134-2026- Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
5ae7ea0819864b5e0bbd2df3333ace11afb650aed9e7e2e2b3e481aeb89ac2c0- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)