Class II — TELEFLEX LLC
| Recalling firm | Teleflex |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). |
| Product | Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor |
| Quantity | 32 units |
| Distribution | Nationwide and Australia, Canada, S. Korea, Singapore |
| Initiated | 2023-05-25 |
| Classified | 2023-07-05 |
| Recall number | Z-2097-2023 |
| 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 — TELEFLEX LLC (Z-2097-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92416/
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