DIAMOND-FLEX CIRCULAR RETRACTOR — Class I medical device recall Z-2212-2016
Terminated recall by Carefusion 2200 Inc, reported 2016-08-03, distributed in MD, WA. BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in
| Recall number | Z-2212-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2016-07-01 |
| Classified | 2016-07-22 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-03-29 |
| Distributed | MD, WA |
| Countries outside the US | JP |
| Quantity | 10 |
| Lot numbers | 878971, 879366, 879404, C16 |
Product
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Reason for recall
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
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-2212-2016. 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.