CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

Pilling Lowsley Prostatic Tractor Str recalled by Teleflex

Teleflex is recalling Pilling Lowsley Prostatic Tractor Str, distributed nationwide in the US. The recall was initiated on 25 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, W1,

Quantity recalled32 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2097-2023
FDA event ID: 92416
Recalling firm: Teleflex, Morrisville, NC
Classification: Class II
Status: Ongoing
Recall initiated: 25 May 2023
FDA classified: 5 Jul 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

25 May 2023	Recall initiated by company
5 Jul 2023	Classified by FDA	+41 days
12 Jul 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

Where it was distributed

Nationwide and Australia, Canada, S. Korea, Singapore

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Numbers: A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, W1,

Where was it sold?

Nationwide and Australia, Canada, S. Korea, Singapore

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 92416

This product is part of a recall event; the main page for the event is Pilling Lowsley Prostatic Tractor Cvd recalled by Teleflex.

Reported	Class	Recall	Company	Reason	Where
12 Jul 2023	CLASS II	Pilling Lowsley Prostatic Tractor Cvd recalled by Teleflex	Teleflex	Other	Nationwide
12 Jul 2023	CLASS II	Pilling O'reilly Esophageal Retractor recalled by Teleflex	Teleflex	Other	Nationwide

More recalls from Teleflex

All 151

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Pilling Wecksorb Neurosponges recalled by Teleflex	Teleflex	Device Malfunction	Nationwide
12 Jul 2023Device	CLASS II	Pilling O'reilly Esophageal Retractor recalled by Teleflex	Teleflex	Other	Nationwide
12 Jul 2023Device	CLASS II	Pilling Lowsley Prostatic Tractor Cvd recalled by Teleflex	Teleflex	Other	Nationwide
5 Jul 2023Device	CLASS I	Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal recalled	Teleflex	Other	Nationwide
5 Jul 2023Device	CLASS I	Preformed AGT Oral Endotracheal Tube Murphy Eye recalled by Teleflex	Teleflex	Other	Nationwide

Other Surgical Instruments recalls

All 3,891

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide