Hospira Symbiq Infusion System Recalled for Secondary Audio Signal Failure
Hospira Inc. is recalling 2,791 Symbiq Infusion Systems because the secondary audio signal fails to activate. The devices were distributed across 22 US states.
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 recall is classified as FDA Class II, and the failure of a secondary audio signal in a medical infusion device presents a risk of harm (potential dosing errors or missed alerts) even though no specific injuries are reported in the source text.
Plain-English summary
Hospira Inc. is recalling 2,791 units of the Hospira Symbiq Infusion System. The recall was initiated because the devices' secondary audio signal fails to activate. The Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via various routes of administration, including parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation.
The affected devices were distributed in the United States, including the states of Alabama, California, Connecticut, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, South Dakota, Texas, and Washington. The recall covers specific serial numbers associated with List Numbers 16206 and 16027.
Hospira Inc. is the recalling firm. Users should check their device serial numbers against the provided lists to determine if their unit is affected. No specific consumer instructions or corrective actions are detailed in the source text beyond the identification of the defect.
The recalled product
- Product
- The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 2,791
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 (20)
- *** 1) List Number 16206
- Serial Numbers: 0017234975
- 0017234978
- 0017234979
- 0017234980
- 0017234981
- 0017234982
- 0017234983
- 0017234984
- 0017234985
- 0017234986
- 0017234988
- 0017234991
- 0017234992
- 0017234993
- 0017234994
- 0017234995
- 0017234996
- 0017234997
- 0017234998
Distribution
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 · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12