Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 10, 2013
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Animas Corporation recalled Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for con… - a critical-severity action.
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for con… was recalled by Animas Corporation in April 10, 2013. Reason: Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The co…. Check the official notice for the remedy. Verify recall #Z-0993-2013 with the FDA Devices before acting.
The recall
Animas Corporation issued this critical-severity FDA Devices recall-Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The co….
- Critical
- severity level
- Class I
- classification
- April 10, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0993-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0993-2013) was formally reported on April 10, 2013, with the manufacturer initiating the action on January 3, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Animas Corporation is listed as the recalling firm, operating out of West Chester, PA. Federal records list the affected scope as 7,157 (494 US pumps affected).
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7,157 (494 US pumps affected)
Related Recalls
6
3 from same agency
Product description
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0993-2013 |
| Date reported | April 10, 2013 |
| Date initiated | January 3, 2013 |
| Recalling firm | Animas Corporation |
| Firm location | West Chester, PA |
| Affected scope | 7,157 (494 US pumps affected) |
| Distribution | 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0993-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.. Recalled by Animas Corporation. Units affected: 7,157 (494 US pumps affected).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2013. Severity: Critical. Recall number: Z-0993-2013.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0993-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 10, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.