Z-2095-2023Class II

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

Name: Z-2095-2023 Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Creator: Teleflex Llc
Published: 2023-05-25
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2023-05-25 / Open, Classified / root cause: labeling and UDI

FDA source

TELEFLEX LLC began a recall of Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor on 2023-05-25. FDA classified it as Class II and gives the reason as "There are incomplete pre-cleaning instructions within the Instructions for Use (IFU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2095-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-25
Posted: 2023-07-05
Recalling firm: Teleflex Medical
Product: Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Product code: KAL Retractor, Ent
Reason for recall: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Root cause tag: labeling and UDI
FDA 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 in commerce: 365 units
Distribution: Nationwide and Australia, Canada, S. Korea, Singapore
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2095-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2095-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-05
Z-2096-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-05
Z-2097-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-05

Product code KAL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)