Key facts
| Recalling firm | ICU Medical, Inc. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Plum Duo Precision IV Pump, 40002-0403 |
| Classification | Class II |
| Recall number | Z-2313-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is ICU Medical, Inc. and the affected product is described in FDA's record as: Plum Duo Precision IV Pump, 40002-0403. FDA's stated reason for the recall is: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.. The recall is tracked under FDA recall number Z-2313-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Plum Duo Precision IV Pump, 40002-0403 -- and the recall number Z-2313-2026. If it matches, stop using or distributing it and contact ICU Medical, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
ICU Medical, Inc.’s FDA history
Argus HQ has recorded 4 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Plum Duo Precision IV Pump, 40002-0403) and recall number Z-2313-2026, then follow ICU Medical, Inc.'s recall instructions.
- Has ICU Medical, Inc. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 4 total FDA actions tied to ICU Medical, Inc., including 4 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2313-2026.
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Related enforcement actions
Full FDA history for ICU Medical, Inc.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Plum Duo Precision IV Pump, 40002-0403 by ICU Medical, Inc. — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-icu-medical-inc-z-2313-2026
"FDA Class II Recall: Plum Duo Precision IV Pump, 40002-0403 by ICU Medical, Inc. — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-icu-medical-inc-z-2313-2026.
Argus HQ Research. "FDA Class II Recall: Plum Duo Precision IV Pump, 40002-0403 by ICU Medical, Inc. — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-icu-medical-inc-z-2313-2026.
@misc{argushq_argushq_ai_recall_fda_recall_icu_medical_inc_z_2313_2026_2026,
title = {FDA Class II Recall: Plum Duo Precision IV Pump, 40002-0403 by ICU Medical, Inc. — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-icu-medical-inc-z-2313-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗