Prime Big Wheel Stretcher-used as a short-term outpatient clinical… — Class II medical device recall Z-2208-2021
Ongoing recall by Stryker Medical Division of Stryker Corporation, reported 2021-08-18, distributed nationwide. Medical devices intended for use in a healthcare facility were distributed to residential customers and may be
| Recall number | Z-2208-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2021-05-12 |
| Classified | 2021-08-06 |
| Reported by FDA | 2021-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CO, IN, MX, TH |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613327278330 |
| Model numbers | 1115, 1115000030 |
Product
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
Reason for recall
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
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-2208-2021. 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.