Henry Schein CardioChek Plus Professional Analyzer — Class II medical device recall Z-0835-2020
Terminated recall by Polymer Technology Systems, Inc., reported 2020-01-29, distributed nationwide. One brand of batteries have a small dimensional difference in the negative button terminal, which, when the ba
| Recall number | Z-0835-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymer Technology Systems, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-12-02 |
| Classified | 2020-01-21 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2020-07-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BM, CA, CH, CL, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, IN, IQ, IT, JO, KR, KY, LB, LT, MA, MX, PA, PH, PL, QA, RO, SA, SE, TT, ZA |
| Quantity | 44,448 total |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00304040037713 |
Product
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Reason for recall
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
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-0835-2020. 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.