Animas 2020 Insulin Pump Recall for False Alarm Component Issue
Animas Corporation is recalling 7,157 Animas 2020 insulin pumps due to a component issue that may cause false alarms for loss of prime, occlusion, or no cartridge detected.
What this means for you
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 I, which the rubric defines as unlikely to cause adverse health consequences. The hazard is limited to false alarms, with no reported injuries or illnesses.
Plain-English summary
Animas Corporation is recalling the Animas(R) 2020 Insulin Infusion Pump. The recall involves 7,157 units, including 494 pumps in the United States. The product is indicated for the continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
The recall was initiated because Animas identified a component issue affecting a small supply of the pumps. This issue may trigger the devices to sound false alarms or warnings related to loss of prime, occlusion, or no cartridge detected.
The affected pumps were distributed worldwide, including nationwide in the United States and in several other countries. Consumers should check their pump's serial number against the list provided by the manufacturer to determine if their device is affected.
The recalled product
- Product
- Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
- Manufacturer
- Animas Corporation
- Category
- Medical Device — Insulin Pump
- Hazard
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 (9)
- Part Numbers 101370-00
- 101371-00
- 101372-00
- 101374-00
- 101375-00
- 100380-00
- 100381-00
- 100382-00
- 100384-00
Distribution
Related recalls
Same manufacturer · Animas Corporation
See all →- SevereAnimas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
FDA (Devices) · 2015-02-11
- ModerateAnimas Vibe Insulin Infusion Pump Recalled for Keypad Wear Issues
FDA (Devices) · 2014-11-05
- ModerateAnimas Vibe Insulin Pump Recalled for Incorrect Hebrew Translation
FDA (Devices) · 2014-11-05
- HighAnimas Insulin Pumps Cease Operation Due to Calendar Date Limit
FDA (Devices) · 2013-02-27
- ModerateAnimas Insulin Pumps Recalled for Keypad Wear and Peeling
FDA (Devices) · 2012-10-10
Same hazard · false alarm
See all →- ModerateDialysis control units recalled over false blood leak detection alarms
FDA (Devices) · 2025-09-03
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
- SevereInfusomat Space Infusion Pump Recall Due to Sensor Malfunction
FDA (Devices) · 2024-09-18
- HighBedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms
FDA (Devices) · 2024-06-12