Data Foundry

Medical device recalls 2013

Animas — Class III medical device recall Z-0836-2013

Terminated recall by Animas Corporation, reported 2013-02-27, distributed nationwide. Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 201

Recall numberZ-0836-2013
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAnimas Corporation, West Chester, PA, United States
Recall initiated2012-12-17
Classified2013-02-17
Reported by FDA2013-02-27
Terminated2013-12-24
DistributedNationwide (US)
Countries outside the USAT, AU, BM, CA, CZ, DE, DK, ES, FI, FR, GB, HU, IE, IL, IT, MX, NO, NZ, SE
Quantity37,998
Model numbers100170-00, 100171-00, 100172-00, 100200-00, 100201-00, 100202-00, 100210-00, 100211-00, 100212-00, 100250-00, 100251-00, 100252-00, 100380-00, 100381-00, 100382-00, 100384-00, 100385-00, 100450-00, 101370-00, 101371-00, 101372-00, 101374-00, 101375-00

Product

Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.

Reason for recall

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.

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-0836-2013. 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.