Lower risk Medical device recall · FDA · Published May 25, 2023

Teleflex Pilling Lowsley Prostatic Tractor CVD Retractor Recall: Incomplete Cleaning

Teleflex recalls specific model Pilling Lowsley Prostatic Tractor CVD retractors due to incomplete pre-cleaning instructions in the manual. Affected units have lot numbers C7 through W1. Consumers should check their product details and contact Teleflex for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2096-2023Medical device Teleflex ›

Lower-risk recall

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Take action

Contact the company

Recalling firmTELEFLEX LLC3015 Carrington Mill Blvd · Morrisville, NC 27560-5437

✎ GovInfoNow plain-language explainer

Teleflex is recalling certain Pilling Lowsley Prostatic Tractor CVD retractors because the instructions for pre-cleaning are incomplete. This could lead to improper cleaning and potential complications during medical procedures. The recall affects specific lot numbers of the product. Read more at govinfonow.com/recall/57986-teleflex-pilling-lowsley-prostatic-tractor-cvd-retractor-recall-incomplete-cleaning.

Source Summary by GovInfoNow · govinfonow.com/recall/57986-teleflex-pilling-lowsley-prostatic-tractor-cvd-retractor-recall-incomplete-cleaning · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2096-2023

Cite this page

“Teleflex Pilling Lowsley Prostatic Tractor CVD Retractor Recall: Incomplete Cleaning.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57986-teleflex-pilling-lowsley-prostatic-tractor-cvd-retractor-recall-incomplete-cleaning. Based on FDA recall #Z-2096-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2096-2023%22&limit=1).

The FDA announced on May 25, 2023, that Teleflex LLC is voluntarily recalling the Pilling LOWSLEY PROSTATIC TRACTOR CVD retractor due to incomplete pre-cleaning instructions in the Instructions for Use. The recall affects 170 units distributed nationwide and in Australia, Canada, South Korea, and Singapore.

How to tell if you have it

Brand: Teleflex
Product: Pilling LOWSLEY PROSTATIC TRACTOR CVD; retractor
REF: 243200
Lot Numbers: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, W1
Quantity: 170 units
Distribution: Nationwide and Australia, Canada, S. Korea, Singapore

The hazard

According to the FDA, the hazard stems from incomplete pre-cleaning instructions within the Instructions for Use (IFU) for the device.

Context

GovInfoNow's records show Teleflex LLC has initiated eight other recalls since August 29, 2022. Other recent recalls of similar products include Pilling Wecksorb Neurosponges Recall (May 7, 2026), Teleflex Preformed AGT Oral Endotracheal Tube Recall (May 25, 2023), and Teleflex Horizon Microclip Clips Recall (April 28, 2023). Other recent recalls of similar products include ReCor Paradise Ultrasound Renal Denervation System Recall (January 29, 2026), Stryker BARD EP XT Steerable Catheter Recall (April 10, 2026), and Medline Convenience Kits Recall (July 10, 2026).

How to tell if you have this one

Check the lot number on the retractor, which is listed as C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, W1. The product is a Pilling Lowsley Prostatic Tractor CVD retractor.

Brand
Teleflex
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide and Australia, Canada, S. Korea, Singapore

Recall number	Product, codes & lots	Quantity
Z-2095-2023	Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor; 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	365 units
Z-2096-2023	Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor; Lot Numbers: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, W1	170 units
Z-2097-2023	Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor; Lot Numbers: A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, W1,	32 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number on the retractor, which should be one of the listed numbers: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, W1.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide and Australia, Canada, S. Korea, Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 48 days after the firm started it.

May 25, 2023Firm started the recall
Jul 5, 2023FDA classified it Class II
Jul 12, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57986-teleflex-pilling-lowsley-prostatic-tractor-cvd-retractor-recall-incomplete-cleaning">Teleflex Pilling Lowsley Prostatic Tractor CVD Retractor Recall: Incomplete Cleaning (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2096-2023 (May 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2096-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.