STERIS Boot Assembly — Class II medical device recall Z-1289-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-03-20, distributed nationwide. Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an inco
| Recall number | Z-1289-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-02-14 |
| Classified | 2024-03-12 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 14 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00615521000851 |
| Lot numbers | 23-140, 23-268, 23-314 |
| Model numbers | 10009192 |
Product
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Reason for recall
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
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-1289-2024. 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.