Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

FDA Recall Z-2095-2023 · Posted 2023-07-05

Recalling FirmTELEFLEX LLC
Recall StatusOpen, Classified
Product CodeKAL
Date Initiated2023-05-25
Product Quantity365 units

Reason for Recall

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Firm Action

Teleflex issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/25/2023 by Fed Ex 2nd day delivery. The notice explained the problem, the risk to health, and requested the following actions be taken: Medical facilities are to check the facilities for the product and place a copy of the notice with it. Distributors are directed to check for the product and place a copy of the notice with the product, and notify all customers to whom the product has been distributed.

Root Cause

Other

Distribution Pattern

Nationwide and Australia, Canada, S. Korea, Singapore

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑