Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 18, 2023
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the for…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Smiths Medical Asd Inc. recalled Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 - a moderate-severity action.
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 was recalled by Smiths Medical Asd Inc. in October 18, 2023. Reason: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detectio…. Check the official notice for the remedy. Verify recall #Z-0076-2024 with the FDA Devices before acting.
The recall
Smiths Medical Asd Inc. issued this moderate-severity FDA Devices recall-A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detectio….
- Moderate
- severity level
- Class II
- classification
- October 18, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0076-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0076-2024) was formally reported on October 18, 2023, with the manufacturer initiating the action on August 16, 2023. 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 20815 pumps.
The documented reason for this recall is: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large eno… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the country of Canada.. 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
20815 pumps
Related Recalls
6
3 from same agency
Product description
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Reason for recall
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0076-2024 |
| Date reported | October 18, 2023 |
| Date initiated | August 16, 2023 |
| Recalling firm | Smiths Medical Asd Inc. |
| Firm location | Minneapolis, MN |
| Affected scope | 20815 pumps |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
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-0076-2024) 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 Syringe Pump, Model 3500-500, v3, v4, v5, and v6. Recalled by Smiths Medical Asd Inc.. Units affected: 20815 pumps.
Why was this product recalled? ▼
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0076-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0076-2024) 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.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
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 October 18, 2023. 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.