Hospira GemStar Infusion Pump Recall for Potential Over-Infusion Risk
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.
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. The hazard involves a mechanical defect leading to over-infusion of medication, which poses a significant risk of injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
Hospira Inc. is recalling specific GemStar infusion pumps due to a defect in the motor assembly. The GemStar Pump is a small, single-channel electronic infusion device designed for use in homes, hospitals, or other settings requiring electronic infusion. It can be powered by AC mains, rechargeable batteries, a docking station, or disposable AA batteries.
The recall is issued because, during infusions set at 2.0 mL/hr, the motor assembly may rotate backwards. This malfunction can result in the pump capturing additional medication, leading to over-infusion. The affected units are identified by List Numbers 13000, 13100, and 13150.
The recall covers pumps distributed worldwide, including the United States and numerous international markets. Users of these devices should stop using the affected pumps and contact Hospira Inc. for further instructions on replacement or repair.
The recalled product
- Product
- The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
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)
- List Numbers: 13000
- 13100
- 13150
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 Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16
Same hazard · over infusion
See all →- HighSIGMA Spectrum infusion pumps recalled over defective grease on the gears
FDA (Devices) · 2026-01-28
- CriticalInfusion pump modules recalled because drops can damage the bezel assembly
FDA (Devices) · 2025-11-26
- HighInfusion pumps recalled because degrading grease may cause excessive therapy delivery
FDA (Devices) · 2025-09-03
- HighInfusion Pump Manual Instructs Users to Leave Safety Clamp Open
FDA (Devices) · 2025-03-05
- HighIvenix Infusion System Software Defect May Delay or Cause Incorrect Infusions
FDA (Devices) · 2024-03-20
Similar recalls
- SevereHospira GemStar Infusion Pumps Recalled for Unintended Shutdowns
FDA (Devices) · 2013-05-08
- CriticalHospira Recalls GemStar Infusion Pumps Due to Unexpected Shutdowns
FDA (Devices) · 2013-05-08
- SevereHospira Recalls GemStar Infusion Pumps Due to Battery Data Loss
FDA (Devices) · 2013-05-08
- SevereHospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift
FDA (Devices) · 2013-11-27
- HighHospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access
FDA (Devices) · 2014-12-03
- SevereHospira Recalls GemStar Docking Stations Due to Power and Voltage Issues
FDA (Devices) · 2014-05-07