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.
What this means for you
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
- Hazard
- incomplete-instructions
- sterilization-risk
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.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03