Neria Soft Infusion Sets recalled due to incorrect instruction manual
Unomedical A/S is recalling 10,770 units of Neria Soft Infusion Sets because certain lots were shipped with incorrect instructions for use. The wrong instruction manual for Rest of World markets was included instead of the FDA-approved US version.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (intravascular administration device with incorrect instructions that could affect proper use) where no injuries have been reported, meeting the criteria for High severity per the rubric.
Plain-English summary
Unomedical A/S is recalling specific lots of Neria Soft Infusion Sets (Product Code 507302), intravascular administration sets used for medication and fluid infusion. The affected units were shipped with incorrect Instructions for Use (IFU) in the final package.
The incorrect instructions are the version registered for Rest of World markets rather than the FDA-approved US version. The primary difference between the two versions is the addition of an intended use section in the Rest of World instructions.
The recall affects 10,770 units bearing Lot Numbers 5277396 and 5371146 (UDI/DI 05705244001558). These units were distributed in Florida.
Healthcare facilities and medical professionals should immediately verify they possess the correct FDA-approved US Instructions for Use. If you have affected units, contact Unomedical A/S for replacement instructions. Do not use the Rest of World instructions for device operation or clinical decisions.
The recalled product
- Product
- Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Manufacturer
- Unomedical A/S
- Hazard
- incorrect-instructions
- labeling-error
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 (3)
- UDI/DI 05705244001558
- Lot Numbers: 5277396
- 5371146
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03