Teleflex Pilling O'Reilly Esophageal Retractor Recalled for Incomplete Cleaning Instructions
TELEFLEX LLC recalled the Pilling O'REILLY ESOPHAGEAL RETRACTOR (REF 381801A) due to incomplete pre-cleaning instructions in the product's Instructions for Use. The recall affects 365 units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries. The hazard is incomplete cleaning instructions, which is a documentation issue rather than a product defect. The precautionary nature of the recall and the absence of reported harm support a Moderate severity rating.
Plain-English summary
The Pilling O'REILLY ESOPHAGEAL RETRACTOR (REF 381801A), manufactured by TELEFLEX LLC, is being recalled due to incomplete pre-cleaning instructions in the product's Instructions for Use (IFU).
The recall involves 365 units distributed nationwide across the United States, as well as Australia, Canada, South Korea, and Singapore. Affected lot numbers include: 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.
Incomplete cleaning instructions may result in inadequate cleaning and sterilization of the surgical instrument prior to use.
The recalled product
- Product
- Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
- Manufacturer
- TELEFLEX LLC
- Category
- Medical Device — ENT Instruments
- Affected units
- 365
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: B5
- B6
- B9
- C6
- C7
- D2
- D6
- E5
- E9
- F2
- F3
- F5
- F8
- G4
- G5
- G9
- I3
- I4
- I7
- I8
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by TELEFLEX LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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