Hospira Symbiq Infuser Recall for Potential White Screen Error
Hospira is recalling Symbiq One Channel Infusers because a white screen during KVO titration may allow premature programming, potentially causing therapy delays and significant injury.
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: The source text explicitly states the error could "potentially result in significant injury," which aligns with the rubric criterion for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Hospira Inc. is recalling 35,596 Symbiq One Channel Infusers, prescription medical devices used to administer intravenous fluids, medications, and blood products. The devices were distributed nationwide in the United States and in Canada.
The recall is due to a potential software error where the device may display a white screen during the titration of a Keep Vein Open (KVO) delivery. This error can allow a clinician to select the "NEXT" button before the programming is complete. If this occurs, it could result in a delay in therapy, which potentially leads to significant injury.
Healthcare facilities should check their inventory for affected devices using the provided lot codes and contact Hospira for further instructions on the recall process.
The recalled product
- Product
- Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administratio
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 35,596
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · software error
See all →- HighDASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
FDA (Devices) · 2026-08-12
- HighQuantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk
FDA (Devices) · 2026-08-12
- HighQuantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
FDA (Devices) · 2026-08-12
- HighQuantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
FDA (Devices) · 2026-08-12
- HighREMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting
FDA (Devices) · 2026-08-12