Z-0137-2015Class II

Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous...

Name: Z-0137-2015 Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous...
Creator: Animas Corporation
Published: 2012-10-25
License: https://open.fda.gov/license/

Animas Corp. / initiated 2012-10-25 / Terminated / root cause: design

FDA source

Animas Corporation began a recall of Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of... on 2012-10-25. FDA classified it as Class II and gives the reason as "Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0137-2015
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Posted: 2014-10-24
Terminated: 2015-06-29
Recalling firm: Animas Corp.
Product: Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.
Root cause tag: design
FDA root cause: Device Design
Action: Animas initiated the notification to Distributors by letter, dated July 2012, and Patients and Health Care Professionals were notified by letter in September 2012. The delay in notifying patients and health care professionals was driven by the need to have sufficient inventory of replacement product on hand in order to meet anticipated demand before sending the letters.
Quantity in commerce: 1938
Distribution: Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
Product codes and lots: Part Numbers 101200-57 100512-57 100510-02 100510-03 100510-04 100510-53 100510-56 100510-57 100510-63 100510-67 100511-02 100511-03 100511-04 100511-53 100511-56 100511-57 100511-63 100512-02 100512-02 100512-03 100512-04 100512-53 100512-56 100512-57 100512-63 100514-02 100514-03 100514-04 100514-53 100514-56 100514-57 100514-63 100515-02 100515-03 100515-04 100515-53 100515-56 100515-57 100515-63 101200-02 101002-03 101002-53 101002-56 101002-57 101002-63 101201-02 101201-03 101201-53 101210-56 101201-57 101201-63 101202-02 101202-03 101202-04 101202-53 101202-57 101202-63 101204-03 101204-04 101204-53 101204-57 101204-63 101205-03 101205-53 101205-56 101205-57 101205-63

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0137-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24

Product code LZG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)