FDA recall Z-2095-2023

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).

Distribution

Nationwide and Australia, Canada, S. Korea, Singapore

Key facts

Status

Ongoing

Initiation date

2023-05-25

Report date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2095-2023