Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 25, 2013
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power recep…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Smiths Medical Asd, Inc. recalled Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are desi… - a moderate-severity action.
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are desi… was recalled by Smiths Medical Asd, Inc. in December 25, 2013. Reason: Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical …. Check the official notice for the remedy. Verify recall #Z-0540-2014 with the FDA Devices before acting.
The recall
Smiths Medical Asd, Inc. issued this moderate-severity FDA Devices recall-Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical ….
- Moderate
- severity level
- Class II
- classification
- December 25, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0540-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0540-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on November 22, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Smiths Medical Asd, Inc. is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 9560 (8601 US, 959 OUS).
The documented reason for this recall is: Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline so… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, S…. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9560 (8601 US, 959 OUS)
Related Recalls
6
3 from same agency
Product description
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
Reason for recall
Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC po
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0540-2014 |
| Date reported | December 25, 2013 |
| Date initiated | November 22, 2013 |
| Recalling firm | Smiths Medical Asd, Inc. |
| Firm location | Saint Paul, MN |
| Affected scope | 9560 (8601 US, 959 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUST… |
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-0540-2014) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.. Recalled by Smiths Medical Asd, Inc.. Units affected: 9560 (8601 US, 959 OUS).
Why was this product recalled? ▼
Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC po
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0540-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0540-2014) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 25, 2013. 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 July 2026.