ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) recall: In a specific scenario, the pump will not decrement the Volume to be Infused
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2723-2026
- Published
- July 22, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical, Inc.
- Product type
- Medical devices
- Units affected
- 12525 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 1) UDI/DI +M335400021, Serial Numbers: 50003704, 50003710, 50004046, 50004072, 50004149, 50004154, 50004156, 50004163, 50004166, 50004168, 50004177, 50004183, 50004205, 50004218, 50004220, 50004249, 50004258, 50004262, 50004263, 50004264, 50004271, 50004300, 50004303, 50004304, 50004305, 50004307, 50004308, 50004310, 50004312, 50004314, 50004316, 50004318, 50004319, 50004323, 50004324, 50004325, 50004326, 50004328, 50004330, 50004331, 50004332, 50004333, 50004334, 50004335, 50004336, 50004338, 50004339, 50004340, 50004341, 50004342, 50004344, 50004345, 50004346, 50004347, 50004348, 50004349, 50004350, 50004351, 50004352, 50004356, 50004358, 50004359, 50004361, 50004363, 50004365, 50004366, 50004370, 50004372, 50004373, 50004374, 50004376, 50004380, 50004382, 50004383, 50004384, 50004385, 50004386, 50004387, 50004389, 50004390, 50004391, 50004392, 50004393, 50004394, 50004395, 50004396, 50004398, 50004399, 50004401, 50004403, 50004405, 50004407, 50004409, 50004410, 50004411, 50004413, 50004415, 50004416, 50004417, 50004424, 50004425, 50004426, 50004428, 50004431, 50004433, 50004435, 50004436, 50004438, 50004439, 50004442, 50004443, 50004444, 50004445, 50004448, 50004449, 50004451, 50004452, 50004455, 50004458, 50004460, 50004461, 50004462, 50004464, 50004465, 50004467, 50004468, 50004469, 50004471, 50004472, 50004473, 50004474, 50004477, 50004481, 50004482, 50004486, 50004487, 50004493, 50004495, 50004499, 50004501, 50004502, 50004506, 50004510, 50004512, 50004513, 50004515, 50004519, 50004521, 50004522, 50004541, 50004552, 50004553, 50004558, 50004559, 50004561, 50004570, 50004571, 50004576, 50004578, 50004579, 50004581, 50004583, 50004586, 50004593, 50004595, 50004599, 50004605, 50004607, 50004608, 50004609, 50004616, 50004631, 50004636, 50004637, 50004642, 50004649, 50004654, 50004655, 50004660, 50004664, 50004665, 50004669, 50004670, 50004671, 50004712, 50004724, 50004756, 50004773, 50004891, 50004907, 50004913, 50004930, 50004939, 50004940, 50005000, 50005001, 50005012, 50005014, 50005018, 50005020, 50005021, 50005027, 50005037, 50005039, 50005040, 50005047, 50005050, 50005057, 50005058, 50005060, 50005065, 50005077, 50005081, 50005096, 50005101, 50005134, 50005184, 50005185, 50005199, 50005205, 50005275, 50005290, 50005328, 50005360, 50005384, 50005425, 50005446, 50005586, 50005594, 50005596, 50005598, 50005599, 50005600, 50005605, 50005607, 50005608, 50005611, 50005615, 50005621, 50005622, 50005623, 50005628, 50005636, 50005637, 50005640, 50005647, 50005648, 50005656, 50005659, 50005660, 50005664, 50005665, 50005666, 50005668, 50005670, 50005671, 50005673, 50005676, 50005683, 50005689, 50005692, 50005695, 50005698, 50005705, 50005706, 50005720, 50005721, 50005722, 50005724, 50005725, 50005726, 50005727, 50005728, 50005735, 50005747, 50005750, 50005752, 50005753, 50005757, 50005758, 50005762, 50005768, 50005770, 50005771, 50005772, 50005775, 50005778, 50005783, 50005785, 50005798, 50005807, 50005808, 50005814, 50005815, 50005823, 50005826, 50005827, 50005829, 50005830, 50005835, 50005843, 50005845, 50005847, 50005848, 50005851, 50005855, 50005856, 50005858, 50005861, 50005863, 50005865, 50005867, 50005868, 50005870, 50005871, 50005879, 50005888, 50005890, 50005891, 50005893, 50005902, 50005910, 50005912, 50005917, 50005920, 50005924, 50005925, 50005927, 50005928, 50005934, 50005935, 50005937, 50005939, 50005941, 50005945, 50005958, 50005962, 50005972, 50005975, 50005977, 50005978, 50005983, 50005987, 50005993, 50006001, 50006006, 50006007, 50006008, 50006010, 50006013, 50006020, 50006031, 50006035, 50006039, 50006045, 50006047, 50006050, 50006060, 50006069, 50006073, 50006083, 50006087, 50006090, 50006108, 50006127, 50006135, 50006149, 50006150, 50006151, 50006159, 50006163, 50006177, 50006183, 50006197, 50006198, 50006205, 50006218, 50006227, 50006230, 50006255, 50006273, 50006288, 50006292, 50006297, 50006303, 50006305, 50006307, 50006311, 50006313, 50006314, 50006315, 50006318, 50006324, 50006335, 50006338, 50006339, …
Products covered by this recall
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Check your product
The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Model or item number
On the rating label, the box or the instruction sheet.
- 400020401
- 400020403
Serial number
On the rating plate, often next to the date of manufacture.
- 50003704
- 50003710
- 50004046
- 50004072
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
ICU Medical, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: ICU Medical, Inc. — 600 N Field Dr, Lake Forest, IL, 60045-4835
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was ICU Medical, Inc. medical devices recalled?
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: model number 400020401, 400020403. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. Plum administration sets recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Non-Dedicated Gravity Administration Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…