Custom Breast Biopsy Tray w/Sodium Chloride — Class II medical device recall Z-0797-2013
Terminated recall by Custom Healthcare Systems, Inc., reported 2013-02-13, distributed nationwide. Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
| Recall number | Z-0797-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Healthcare Systems, Inc., Richmond, VA, United States |
| Recall initiated | 2012-11-26 |
| Classified | 2013-02-07 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 80 trays |
| Reason classes | specification failure |
| Lot numbers | 2012, 60812 |
| Model numbers | B9-15263A |
Product
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Reason for recall
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
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-0797-2013. 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.