Smiths Medical Medfusion model 3010a syringe Infusion pump.… recallZ-0651-2010 · Smiths Medical ASD, Inc. · initiated Nov 16, 2009

Terminated All recalls posted in January 2010

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the Pump. The Pump is designed so that when its so

FDA root cause category: Device Design

What the company is doing

An Urgent Medical Device Recall letter, dated November 16, 2009, was sent to customers beginning November 16, 2009. The letter described the issue, identified affected devices, and asked that affected devices be returned to Smiths Medical to be inspected, repaired, if necessary, and returned back to medical facility. A Confirmation Form is also asked to be completed and returned to Smiths Medical. To return Pumps or for questions regarding this Urgent Recall Notice, please contact Smiths Medical Customer Service Department at 1~866-270-7060. Please report any issues with these Pumps please contact Smiths Medical Technical Customer Service Department at 1866-216-8806.

Recall details

Recall number: Z-0651-2010
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Nov 16, 2009
Posted by the FDA: Jan 15, 2010
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 43
Product code: FRN
FDA submissions: K040899
Distribution: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY,OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including Guam, Puerto Rico. OUS to include: Canada, Chile, Czech Republic,, England, France, Germany, Hong Kong, Ireland, Israel, Lebanon, Malaysia, Poland, Saudi Arabia, Scotland, Singapore, Sweden, Switzerland, United Arab Emirates.

Product description

Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA)

Code information (models, lots, serial numbers)

serial number: M66331, M66332, M66333, M66334, M66335, M66336, M66337, M66339, M66340, M66341, M66342, M66343, M66344, M66345, M66721, M66722, M66723, M66724, M66725, M66726, M66727, M66728, M66729, M66730, M66731, M66732, M66733, M66734.

Other devices under the same FDA submission

1 device cleared under K040899 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Medfusion 3500-500
Icu Medical, Inc. · Pump, infusion
2 recalls2 deaths1,884 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 53940).

Z-0650-2010 · Terminated
Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA).

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page