FDA Device recall Z-2095-2023
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A by Teleflex, citing there are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2095-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-25 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
Product
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Reason
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Identifiers
| code_info | Lot Numbers: B5, B6, B9, C6, C7, D2, D6, E5, E9, F2, F3, F5, F8, G4, G5, G9, I3, I4, I7, I8, J2, J3, K4, K5, K7, K8, L2, L9, O2, Q0, R2, S2, U0, V2, W1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2095-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.