Data Foundry

Medical device recalls 2021

Infusion Pump — Class II medical device recall Z-1150-2021

Terminated recall by Baxter Healthcare Corporation, reported 2021-03-03, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Battery performance issues related to prolonged storage.

Recall numberZ-1150-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Medina, NY, United States
Recall initiated2021-01-06
Classified2021-02-25
Reported by FDA2021-03-03
Terminated2026-05-04
DistributedAK, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the USBB, BM, BS, CA, GY, JM, TT
Quantity589,704 units

Product

Infusion Pump

Reason for recall

Battery performance issues related to prolonged storage.

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-1150-2021. 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.