Recall archive / FDA device enforcement
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor — FDA record Z-2095-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 25, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
- Reason
- There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- Classification
- Class II
- Recalling firm
- TELEFLEX LLC
- Quantity
- 365 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2095-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide and Australia, Canada, S. Korea, Singapore
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 12, 2023
- Recall initiation date
- May 25, 2023
- Center classification date
- Jul 5, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.