Food, drugs, devices › TELEFLEX LLC
Device recall: Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
FDA enforcement event 92416 is a device recall by TELEFLEX LLC of Morrisville, NC, initiated 25 May 2023 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. TELEFLEX LLC has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
TELEFLEX LLC, Morrisville, NC.
Reason for recall
"There are incomplete pre-cleaning instructions within the Instructions for Use (IFU)."
Distribution
"Nationwide and Australia, Canada, S. Korea, Singapore"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2095-2023 | Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor | 365 units | Class II | Ongoing | 12 Jul 2023 |
| Z-2096-2023 | Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor | 170 units | Class II | Ongoing | 12 Jul 2023 |
| Z-2097-2023 | Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor | 32 units | Class II | Ongoing | 12 Jul 2023 |
Context
Other enforcement events for TELEFLEX LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There are incomplete pre-cleaning instructions within the Instructions for Use (IFU)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Australia, Canada, S. Korea, Singapore"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.