CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report

Vibe Insulin Infusion Pump and System recalled by Animas

Animas is recalling Animas Vibe Insulin Infusion Pump and System. The recall was initiated on 25 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled1938

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0137-2015
FDA event ID: 69296
Recalling firm: Animas, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 25 Oct 2012
FDA classified: 24 Oct 2014
Reported: 5 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

25 Oct 2012	Recall initiated by company
24 Oct 2014	Classified by FDA	+729 days
5 Nov 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

Where it was distributed

Worldwide Distribution in the countries of France, Italy, Sweden, and UK..

Questions about this recall

Is Vibe Insulin Infusion Pump and System recalled?

Yes. Animas recalled Vibe Insulin Infusion Pump and System on 25 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0137-2015.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide Distribution in the countries of France, Italy, Sweden, and UK..

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Animas

All 6

Reported	Class	Recall	Company	Reason	Where
11 Feb 2015Device	CLASS II	Vibe Insulin Infusion Pump recalled by Animas	Animas	Device Malfunction	PA
5 Nov 2014Device	CLASS II	Vibe Insulin Infusion Pump recalled by Animas	Animas	Lead & Heavy Metals	Nationwide
10 Apr 2013Device	CLASS I	Animas(R) 2020 Insulin Infusion Pump recalled	Animas	Device Malfunction	Nationwide
27 Feb 2013Device	CLASS III	Animas(R) IR 1200 Insulin Infusion Pumps Indicated recalled	Animas	Device Malfunction	Nationwide
10 Oct 2012Device	CLASS II	IR1200, IR1250(IR1200 Plus) recalled by Animas	Animas	Lead & Heavy Metals	Nationwide

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