Data Foundry

Medical device recalls 2014

The GemStar Power Supply is an accessory for the GemStar Infusion Pump — Class I medical device recall Z-0095-2015

Terminated recall by Hospira Inc., reported 2014-11-05, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, sm

Recall numberZ-0095-2015
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHospira Inc., Lake Forest, IL, United States
Recall initiated2014-02-03
Classified2014-10-24
Reported by FDA2014-11-05
Terminated2017-03-07
DistributedAK, 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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the USAT, BE, BR, CH, DE, ES, FR, GB, GR, NL, SA, SE, TR, ZA
Quantity978 power
Lot numbers25283G1, 26286G1, 26287G1, 27292G1, 27294G1, 27295G1, 27296G1

Product

The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.

Reason for recall

The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.

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-0095-2015. 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.