Insulin Pump Batteries Recalled After Sudden-Shutdown Reports
OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I device recall: failure causes interruption of life-sustaining therapy; hospitalization already reported. Score 5.
Plain-English summary
OmniDose Medical has issued a voluntary device recall for 23,000 lithium-ion battery packs used in its X4 insulin pump platform. The company has received 41 reports of the battery shutting down without warning, which causes the pump to suspend insulin delivery.
A sudden interruption of basal insulin can lead to rapid-onset diabetic ketoacidosis, a life-threatening condition. The FDA has classified this as a Class I device recall. One serious injury (DKA requiring hospitalization) has been reported; no deaths.
Users should keep a backup insulin delivery method available (pens or syringes), check the lot code on the back of the battery pack, and contact OmniDose support for a free replacement battery. Pump itself does not need to be returned.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
- Manufacturer
- Medline Industries, LP
- Affected units
- 380
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI each 10195327487546
- UDI/DI case 40195327487547
- Lot Numbers: 24KME456
- 24HMJ900.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP 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.
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