Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 8, 2013
GemStar Pump - Battery Product Usage: 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 disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able…
Hospira Inc. recalled GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, s… — a critical-severity action.
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, s… was recalled by Hospira Inc. in May 8, 2013. Reason: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's para…. Check the official notice for the remedy. Verify recall #Z-1160-2013 with the FDA Devices before acting.
The recall
Hospira Inc. issued this critical-severity FDA Devices recall — Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's para….
- Critical
- severity level
- Class I
- classification
- May 8, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1160-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1160-2013) was formally reported on May 8, 2013, with the manufacturer initiating the action on March 18, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Hospira Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps.
The documented reason for this recall is: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Ger…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps
Related Recalls
6
6 from same agency
Product description
GemStar Pump - Battery Product Usage: 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 disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Reason for recall
Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1160-2013 |
| Date reported | May 8, 2013 |
| Date initiated | March 18, 2013 |
| Recalling firm | Hospira Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps |
| Distribution | Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Gre… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1160-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GemStar Pump - Battery Product Usage: 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 disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.. Recalled by Hospira Inc.. Units affected: List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps.
Why was this product recalled? ▼
Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2013. Severity: Critical. Recall number: Z-1160-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1160-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 8, 2013.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.