Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 23, 2022
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start …
Smiths Medical Asd Inc. recalled Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe… - a moderate-severity action.
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe… was recalled by Smiths Medical Asd Inc. in February 23, 2022. Reason: There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error co…. Check the official notice for the remedy. Verify recall #Z-0653-2022 with the FDA Devices before acting.
The recall
Smiths Medical Asd Inc. issued this moderate-severity FDA Devices recall-There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error co….
- Moderate
- severity level
- Class II
- classification
- February 23, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0653-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0653-2022) was formally reported on February 23, 2022, with the manufacturer initiating the action on December 3, 2015. It is classified under Moderate severity (Class II), with a current status of Ongoing. Smiths Medical Asd Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 38,797 (31,065 pumps and 7,732 boards).
The documented reason for this recall is: There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-t… Distribution data in the federal record shows the product reached: Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.. 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
38,797 (31,065 pumps and 7,732 boards)
Related Recalls
6
6 from same agency
Product description
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.
Reason for recall
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0653-2022 |
| Date reported | February 23, 2022 |
| Date initiated | December 3, 2015 |
| Recalling firm | Smiths Medical Asd Inc. |
| Firm location | Minneapolis, MN |
| Affected scope | 38,797 (31,065 pumps and 7,732 boards) |
| Distribution | Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution. |
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-0653-2022) 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 Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.. Recalled by Smiths Medical Asd Inc.. Units affected: 38,797 (31,065 pumps and 7,732 boards).
Why was this product recalled? ▼
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 23, 2022. Severity: Moderate. Recall number: Z-0653-2022.
Where was the recalled product distributed? ▼
Distribution: Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0653-2022) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 February 23, 2022. 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 August 2026.