Food, drugs, devices › Animas Corporation
Device recall: Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcuta
FDA enforcement event 64307 is a device recall by Animas Corporation of West Chester, PA, initiated 17 Dec 2012 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 24 Dec 2013. Initiation: voluntary: firm initiated. Animas Corporation has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Animas Corporation, West Chester, PA.
Reason for recall
"Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display."
Distribution
"Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0836-2013 | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin. | 37,998 | Class III | Terminated | 27 Feb 2013 |
Context
Other enforcement events for Animas Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Jun 2014 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the tre | Device | Class II | 1 |
| 3 Jan 2013 | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of in | Device | Class I | 1 |
| 25 Oct 2012 | Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insul | Device | Class II | 1 |
| 16 Jul 2012 | IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intende | Device | Class II | 1 |
| 6 Sep 2011 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the tre | Device | Class II | 1 |
All 6 events for Animas Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Dec 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.