FDA Medical Device Recalls (openFDA)
TELEFLEX LLC: Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
- Recall number
- Z-2095-2023
- Recalling firm
- TELEFLEX LLC
- Product
- Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
- Status
- Open, Classified
- Initiated
- 2023-05-25
- Posted
- 2023-07-05
- Terminated
- not on file
- Reason
- There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- Root cause
- Other
- 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.
- Quantity
- 365 units
- Distribution
- Nationwide and Australia, Canada, S. Korea, Singapore
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KAL
- Firm FEI
- 3005747797
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28