Class II — Theragenics Corporation
| Recalling firm | Theragenics Corporation |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed |
| 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. |
| Quantity | 480 packs (5 needles each) NOTE: The multipacks are part of a box of 25 needles, containing five (5) single packs and four (4) 5-packs. |
| Distribution | Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa. |
| Initiated | 2018-10-09 |
| Classified | 2018-12-19 |
| Terminated | 2020-08-18 |
| Recall number | Z-0643-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Theragenics Corporation (Z-0643-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81537/
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