Theragenics Applicator Needle — Class II medical device recall Z-0643-2019
Terminated recall by Theragenics Corporation, reported 2018-12-26, distributed nationwide. Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
| Recall number | Z-0643-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Theragenics Corporation, Buford, GA, United States |
| Recall initiated | 2018-10-09 |
| Classified | 2018-12-19 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | ZA |
| UPC / GTIN / UDI-DI | 00813787021515 |
| Lot numbers | 180904-80 |
| Model numbers | CPPS-MN-1820, CPPS-MN-1820-5 |
Product
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
Reason for recall
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
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-0643-2019. 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.