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Animas Corp.

United StatesFDA 510(k) applicant, unverified

Devices
71
FDA recalls
28

What Animas Corp. makes

Animas Corp. manufactures insulin infusion pumps, including the R1000 series and Model IR1200/IR1250, designed for continuous subcutaneous insulin delivery. Their portfolio also includes infusion sets like the EZ SET and Animus EZSERter, as well as diabetes management software such as EZManager Max and Symphony for glucose monitoring. Additional products include the GlucoWatch automatic glucose biographer and the Animas Vibe system for integrated diabetes care.

The company’s devices are regulated under FDA pathways, with Class II and Class III classifications. Products are authorised via 510(k) clearances and Premarket Approval (PMA) applications. Animas Corp. is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue71

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FDA recalls28

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Showing the 10 most recent of 28 recalls.

  • 2014

    • 10 Jun 2014 Z-0136-2015 Class II Terminated 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.

  • 2013

    • 3 Jan 2013 Z-0993-2013 Class I Terminated Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected. Distribution: Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN,…
      Full distribution text Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico and the countries of: Australia, Austria, Bermuda, Canada, Czech Republic, Finland, France, Germany, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Spain and the United Kingdom.
      Submission number: K042873

  • 2012

    • 17 Dec 2012 Z-0836-2013 Class III Terminated 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,…
      Full distribution text 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, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Austria, Australia, Bermuda, Canada, New Zealand, Czech Republic, Italy, France, Finland, Hungary, Israel, United Kingdom, Spain, Sweden, Norway, Denmark, Germany, Mexico and Ireland.
      Submission numbers: K032257, K042873
    • 25 Oct 2012 Z-0137-2015 Class II Terminated 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. Distribution: Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
    • 16 Jul 2012 Z-0005-2013 Class II Terminated Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. Distribution: Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom.
      Submission number: K032257
    • 1 Mar 2012 Z-1376-2012 Not yet classified Terminated There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue. Distribution: Worldwide Distribution, (USA) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA ID, IL, IN, KS,…
      Full distribution text Worldwide Distribution, (USA) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada and the territory of Puerto Rico.
      Submission number: K080639

  • 2011

    • 6 Sep 2011 Z-1034-2015 Class II Terminated Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011. Distribution: No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom. Submission number: P130007
    • 29 Jul 2011 Z-3017-2011 Unclassified (pre-2012) Terminated Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery. Distribution: Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of…
      Full distribution text Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of Australia, Finland, France, Israel, Italy, Sweden and the U.K.
    • 25 Feb 2011 Z-1678-2011 Unclassified (pre-2012) Terminated Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking. Distribution: Worldwide Distribution - USA (nationwide) and France. Submission number: K032257

  • 2010

    • 18 Mar 2010 Z-2394-2010 Unclassified (pre-2012) Terminated sensor could be damaged Distribution: Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including…
      Full distribution text Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.
      Submission number: K080639
Show the 25 most recent of 28 recalls

  • 2010

    • 18 Mar 2010 Z-2395-2010 Unclassified (pre-2012) Terminated sensor could be damaged Distribution: Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including…
      Full distribution text Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.
    • 18 Mar 2010 Z-2396-2010 Unclassified (pre-2012) Terminated sensor could be damaged Distribution: Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including…
      Full distribution text Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.
      Submission number: K032257
    • 18 Mar 2010 Z-2397-2010 Unclassified (pre-2012) Terminated sensor could be damaged Distribution: Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including…
      Full distribution text Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.

  • 2009

    • 18 Dec 2009 Z-1560-2010 Unclassified (pre-2012) Terminated Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software. Distribution: The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA Submission number: K080639
    • 2 Nov 2009 Z-0481-2010 Unclassified (pre-2012) Terminated Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect. Distribution: Nationwide distribution, and Canada, Cayman Islands, and Denmark. Submission number: K080587

  • 2008

    • 27 Oct 2008 Z-0955-2009 Unclassified (pre-2012) Terminated incorrect dosing recommendation Distribution: Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX. Submission number: K080639
    • 4 Aug 2008 Z-0283-2009 Unclassified (pre-2012) Terminated display old, inaccurate values for bolus amount delivered and amount of planned bolus totals Distribution: Nationwide Distribution Submission number: K080639
    • 4 Aug 2008 Z-0290-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. Distribution: Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of…
      Full distribution text Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
      Submission number: K080639
    • 4 Aug 2008 Z-0291-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. Distribution: Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of…
      Full distribution text Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
      Submission number: K080639
    • 4 Aug 2008 Z-0292-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. Distribution: Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of…
      Full distribution text Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
      Submission number: K042873
    • 4 Aug 2008 Z-0293-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. Distribution: Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of…
      Full distribution text Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
      Submission number: K032257
    • 4 Aug 2008 Z-0294-2009 Unclassified (pre-2012) Terminated Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. Distribution: Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of…
      Full distribution text Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
      Submission number: K042873

  • 2005

    • 31 Oct 2005 Z-0306-06 Unclassified (pre-2012) Terminated Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. Distribution: The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV. Submission number: K993184
    • 31 Oct 2005 Z-0307-06 Unclassified (pre-2012) Terminated Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. Distribution: The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV. Submission number: K021439
    • 31 Oct 2005 Z-0308-06 Unclassified (pre-2012) Terminated Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. Distribution: The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV. Submission number: K032257