Various SRI Surgical Disposable Accessory Packs — Class II medical device recall Z-2300-2012
Terminated recall by SRI Surgical, reported 2012-09-05, distributed nationwide. Distribution of a product that did not meet specifications. (labeling error)
| Recall number | Z-2300-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SRI Surgical, Tampa, FL, United States |
| Recall initiated | 2008-07-16 |
| Classified | 2012-08-29 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 802,135 |
| Reason classes | labeling |
| Model numbers | BS0507C, BS0679A, BS0781A, BS0852D, BS0852E, BS1209, BS1209A, BS1209B, CL0139M, CL0139N, CL0280F, CL0280G, CL0525H, CL0525I, CL0525J, CL0525K, CL0537H, CL0537I, CL0537J, CL0537K, CL0537L, CL0537N, CL0578C, CL0578D, CL0578E and 475 more |
Product
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
Reason for recall
Distribution of a product that did not meet specifications. (labeling error)
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-2300-2012. 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.