Data Foundry

Medical device recalls 2016

TeleSentry Battery — Class II medical device recall Z-1315-2016

Terminated recall by Scottcare Corporation, reported 2016-04-13, distributed in CA, CT, DE, FL, IL, KS, KY, MA…. The firm received a complaint of the battery exploding while recharging.

Recall numberZ-1315-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmScottcare Corporation, Cleveland, OH, United States
Recall initiated2016-02-25
Classified2016-04-01
Reported by FDA2016-04-13
Terminated2019-02-15
DistributedCA, CT, DE, FL, IL, KS, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, WV
Countries outside the USCA
Quantity9,067 batteries
Serial numbers27313, 27314, 27315, 27316, 27317, 27318, 27319, 27320, 27321, 27322, 27323, 27324, 27325, 27326, 27327, 27328, 27329, 27330, 27331, 27332, 27333, 27334, 27335, 27336, 27337 and 475 more
Model numbers101109, 101109B, TS01

Product

TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.

Reason for recall

The firm received a complaint of the battery exploding while recharging.

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-1315-2016. 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.