Teleflex Surgical Retractor Recalled for Incomplete Pre-Cleaning Instructions
Teleflex LLC is recalling 170 units of the Pilling Lowsley Prostatic Retractor due to incomplete pre-cleaning instructions in the user manual. Incomplete instructions may prevent proper sterilization of the surgical instrument.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is an instruction deficiency rather than a device design flaw. Incomplete pre-cleaning instructions pose a theoretical risk; this documentation-based issue qualifies as a moderate precautionary recall.
Plain-English summary
Teleflex LLC is recalling the Pilling Lowsley Prostatic Tractor CVD (Reference 243200), a surgical retractor used in prostate procedures. The recall affects 170 units distributed nationwide and internationally to Australia, Canada, South Korea, and Singapore.
The recalled devices contain incomplete pre-cleaning instructions in the Instructions for Use (IFU). Incomplete pre-cleaning procedures may prevent adequate sterilization of the instrument, creating a theoretical risk of contamination.
Affected lot numbers are: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, and W1. Healthcare facilities using this device should verify their unit's lot number and contact Teleflex LLC for instructions on corrective action or device replacement.
The recalled product
- Product
- Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
- Manufacturer
- TELEFLEX LLC
- Affected units
- 170
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: C7
- C8
- C9
- D5
- D7
- D9
- E5
- E8
- G4
- H8
- I7
- I9
- J4
- J6
- K8
- L3
- L4
- L6
- L8
- P1
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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