Infusion pump damaged by a drop (Z-2224-2026) — Class I is an estimate of the worst that could happen
A recall began for an infusion pump because a drop or heavy jarring can damage internal parts in a way that is not visible, leaving the device in service. The class is I, which estimates how severe the potential harm is rather than counting harm that occurred.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmFresenius Kabi USA, LLC
- ReasonFresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
- DistributionDomestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
- Recall initiated2026-05-06
Key points
- The recall records that a drop or heavy jarring can damage internal parts invisibly, leaving affected devices in service.
- Described behavior includes inputs registering at arbitrary screen positions untouched, or the screen not responding.
- The class is I, an estimate of how severe potential harm could be rather than a count of harm that occurred.
- Of the 1,408 records this site holds as of 2026-09-04, 319 (22.7%) are Class I; food is 49.3% and drugs 4.9%.
- Class and quantity are separate fields, and neither alone determines whether a recall concerns you.
1Damage that cannot be seen from outside
An infusion pump delivers fluid at a set rate and keeps doing so. What the stated reason records is that a drop or heavy jarring can hurt internal parts, and that the damage is not visible. Because it is not visible, the device stays where it is and continues to be used.
The behavior described is inputs registering at arbitrary points on the screen with nobody touching it, or the screen not responding at all, occurring intermittently and without any pattern that could be predicted.
2What a class actually measures
A class is an estimate of potential, not a record of what happened. So Class I cannot be read as many people were harmed, and Class II cannot be read as this was minor. What a reader wants to know is whether it concerns them, and the class answers only one part of that: how heavy it would be if it did.
3The class distribution differs sharply by product type
The same label appears very differently by product type. Nearly half of food records are Class I, while drugs do not reach 5%. Devices sit at 137 of 779 (17.6%). This does not mean food is dangerous and drugs are safe; it reflects how the worst plausible outcome is estimated within each field. Comparing class proportions across fields without that in mind produces a misreading.
4What the class alone does not settle
This record is Class I with a quantity of 18,444. A later article covers a Class I recall of 4.9 million units, and another covers a Class II recall of 153 systems. Class and quantity are separate fields, and neither alone answers whether a recall concerns you. Reading these records means taking class, product type, quantity, distribution and dates together. This series walks through those fields one at a time.
Why it matters
A recall class estimates how severe an outcome could be. It is neither a record of harm nor a measure of scale. Comparing class proportions across product types invites misreading: food is close to half Class I while drugs do not reach five percent. Deciding whether a recall concerns you takes class alongside product type, quantity, distribution and dates.
FAQ
What is Class I?
Does a higher class mean a larger quantity?
Why do food and drugs differ so much in Class I share?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2224-2026