SureStep Tray — Class III medical device recall Z-2333-2016
Terminated recall by C.R. Bard, Inc., reported 2016-08-10, distributed nationwide. Labeling problem
| Recall number | Z-2333-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2016-06-29 |
| Classified | 2016-08-03 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 530 units |
| Reason classes | labeling |
| Lot numbers | NGZG1722 |
Product
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Reason for recall
Labeling problem
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-2333-2016. 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.