CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc… — Class II medical device recall Z-1234-2017
Ongoing recall by Custom Medical Specialties, Inc., reported 2017-03-01, distributed in ID, OR. Sterility of syringe product could not be assured.
| Recall number | Z-1234-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Medical Specialties, Inc., Pine Level, NC, United States |
| Recall initiated | 2016-09-20 |
| Classified | 2017-02-22 |
| Reported by FDA | 2017-03-01 |
| Distributed | ID, OR |
| Quantity | 80 syringes |
| Reason classes | sterility |
| Lot numbers | 40629-1609, 40631-1609 |
Product
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Reason for recall
Sterility of syringe product could not be assured.
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-1234-2017. 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.