Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss
ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for a critical medical device component. The rule states never go below 4 for FDA Class I classifications. No deaths or reported illnesses are stated in the source text, preventing a higher classification.
Plain-English summary
ICU Medical Inc is recalling 28,656 replacement batteries (List Number SUB0000864) found in the Plum 360 Infusion System (List Number 30010). The recall is due to a manufacturing defect from the battery supplier.
Affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected, resulting in decreased overall battery runtime. The defect affects all devices containing CSB BATTERY with the first two characters displaying as 22 or lower.
The Plum 360 Infusion System is a critical medical device used to deliver medications and fluids to patients. Premature battery failure could interrupt treatment. Healthcare providers and patients using affected units should contact ICU Medical Inc immediately for replacement instructions and guidance.
The recalled product
- Product
- Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
- Manufacturer
- ICU Medical Inc
- Affected units
- 28,656
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by ICU Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · ICU Medical Inc
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · battery failure
See all →- SevereAudi Recalls 2024-2025 Q4 E-Tron Models Due to Battery Fire Risk
NHTSA · 2026-10-21
- SevereVolkswagen Recalls ID.4 Vehicles Due to High Voltage Battery Fire Risk
NHTSA · 2026-09-30
- HighOdyne Recalls Hybrid Systems Due to Traction Battery Fire Risk
NHTSA · 2026-08-12
- HighHeartMate 11 volt lithium ion backup batteries may fail
FDA (Devices) · 2026-06-24
- SevereElgin Pelican Recall: High Voltage Battery Fire Risk
NHTSA · 2026-06-24
Similar recalls
- SeverePlum 360 Infusion Battery Recall Due to Manufacturing Defect
FDA (Devices) · 2024-08-21
- SeverePlum 360/A+ Spare Battery Defect Causes Accelerated Capacity Loss
FDA (Devices) · 2024-08-21
- SeverePlum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect
FDA (Devices) · 2024-08-21
- HighICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction
FDA (Devices) · 2017-11-22
- SevereMedical Device Recall: Counterfeit Batteries in Plum Infusion Systems
FDA (Devices) · 2024-11-27
- HighICU Medical Recalls Plum 360 Infusion Systems Due to Module Disengagement Risk
FDA (Devices) · 2017-08-23