Instructions For Use document of the GPS Trackers — Class II medical device recall Z-0288-2021
Terminated recall by Blue Ortho, reported 2020-11-04, distributed in CA, CO, SC, WI. Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperat
| Recall number | Z-0288-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Ortho, Gieres, N/A, France |
| Recall initiated | 2020-09-10 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2023-05-31 |
| Distributed | CA, CO, SC, WI |
| Quantity | 3,471 units |
| Model numbers | 01-0014-15, 01-0034-19, 01-0072-19, 01-0120-19, 01-0129-19, 01-0200-19, 01-0203-19, 01-0205-14, 01-0216-14, 01-0222-19, 01-0223-19, 01-0232-19, 01-0288-19, 01-0341-14, 01-0342-14, 02-0008-18, 02-0031-17, 02-0044-17, 02-0050-17, 02-0060-17, 02-0061-19, 02-0064-17, 02-0067-17, 02-0079-19, 02-0090-19 and 122 more |
Product
Instructions For Use document of the GPS Trackers.
Reason for recall
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
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-0288-2021. 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.