Nipro Diabetes Systems, Inc. Amigo Insulin Infusion Pump Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amigo Insulin Infusion Pump
Brand
Nipro Diabetes Systems, Inc.
Lot Codes / Batch Numbers
Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.
Products Sold
Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.
Nipro Diabetes Systems, Inc. is recalling Amigo Insulin Infusion Pump due to A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.
Recommended Action
Per FDA guidance
The firm will notify each distributor and user by letter and/or telephone of the recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, FL, IN, NJ, NY, UT, WY
Page updated: Jan 10, 2026