Food, drugs, devices › Animas Corporation
Device recall: Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the tre
Animas Corporation (West Chester, PA) initiated this device recall on 10 Jun 2014; FDA lists 1 product record under event 69293, classified Class II.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 2 Sep 2015. 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
"Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen."
Distribution
"International Distribution in Israel only."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0136-2015 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. | 1028 | Class II | Terminated | 5 Nov 2014 |
Context
Other enforcement events for Animas Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 17 Dec 2012 | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcuta | Device | Class III | 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: "Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "International Distribution in Israel only."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Sep 2015. "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.