Single RIKKI Retractor — Class II medical device recall Z-2818-2020
Terminated recall by Smith & Nephew, Inc., reported 2020-08-26, distributed in CA, CO, CT, GA, HI, IL, IN, KY…. The products were improperly heat treated.
| Recall number | Z-2818-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-08-03 |
| Classified | 2020-08-17 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2026-09-10 |
| Distributed | CA, CO, CT, GA, HI, IL, IN, KY, MA, MD, NC, NY, OK, PA, SD, TN, WA, WI |
| Quantity | 111 units |
| Lot numbers | 18DM07309, 18DM14901, 18FM21215, 18GM20885, 18JM05681, 19EM21519, 19EM21520 |
| Model numbers | 71934609 |
Product
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Reason for recall
The products were improperly heat treated.
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-2818-2020. 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.