Estill Medical Recalls Ultra Battery 1 for Insufficient Charging Capacity
Estill Medical Technologies is recalling 6,886 Ultra Battery 1 units because they may not reach full charge capacity within the standard 60-minute charging period.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (insufficient charge) and labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Estill Medical Technologies, Inc. is recalling 6,886 units of the Ultra Battery 1 (TA-UB1), a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The battery was designed to provide sufficient power to warm and deliver one liter of blood or IV fluid infusion to a trauma patient. The recall covers units distributed nationwide in the United States and internationally to Serbia, with production dates ranging from June 2011 to February 2014.
The recall was initiated because Estill discovered that a fully discharged Ultra Battery 1 will only reach 96.9% of its capacity during a standard 60-minute charging period. To achieve 100% charge capacity, the battery requires a 90-minute charging period. Additionally, the charging voltage range of 10-36V specified on the battery label and in the documentation may be inaccurate or incomplete.
Healthcare facilities and users who have the affected Ultra Battery 1 units should contact Estill Medical Technologies for instructions on how to proceed. The company is working to resolve the charging capacity and labeling issues to ensure the device functions as intended for patient care.
The recalled product
- Product
- Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one…
- Manufacturer
- Estill Medical Technologies, Inc
- Affected units
- 6,886
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 (20)
- 06-2011
- 07-2011
- 08-2011
- 09-2011
- 03-2012
- 04-2012
- 05-2012
- 06-2012
- 07-2012
- 08-2012
- 01-2013
- 03-2013
- 08-2013
- 09-2013
- 10-2013
- 11-2013
- 12-2013
- 01-2014
- 02-2014
- 04-2014
Distribution
Distributed nationwide across the United States.
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