Pilling O'REILLY ESOPHAGEAL RETRACTOR — Class II medical device recall Z-2095-2023
Ongoing recall by TELEFLEX LLC, reported 2023-07-12, distributed nationwide. There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
| Recall number | Z-2095-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX LLC, Morrisville, NC, United States |
| Recall initiated | 2023-05-25 |
| Classified | 2023-07-05 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, KR, SG |
| Quantity | 365 units |
| Model numbers | 381801A |
Product
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Reason for recall
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
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-2095-2023. 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.