Animas — Class I medical device recall Z-0993-2013
Terminated recall by Animas Corporation, reported 2013-04-10, distributed nationwide. Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The comp
| Recall number | Z-0993-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Animas Corporation, West Chester, PA, United States |
| Recall initiated | 2013-01-03 |
| Classified | 2013-04-03 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2015-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BM, CA, CZ, DE, ES, FI, FR, GB, IE, IL, IT, MX, NO, NZ |
| Reason classes | device malfunction |
| Serial numbers | 00-00581-12, 00-02356-12, 00-02532-12, 00-03342-12, 00-04226-12, 00-05029-12, 00-05050-12, 01-00649-12, 01-00744-12, 01-00832-12, 01-01642-12, 01-02276-12, 01-02364-12, 01-03079-12, 01-03086-12, 01-03343-12, 01-05118-12, 02-00488-12, 02-00840-12, 02-02284-12, 02-02365-12, 02-02622-12, 02-04404-12, 02-05052-12, 03-00739-12 and 469 more |
| Model numbers | 100380-00, 100381-00, 100382-00, 100384-00, 100385-00, 101370-00, 101371-00, 101372-00, 101374-00, 101375-00 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0993-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.