RecallRadar

FDA Device recall Z-2097-2023

Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201

On 2023-07-12 the FDA classified a Class II recall of Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201 by Teleflex, citing there are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2097-2023
ClassificationClass II
Statusongoing
Initiated2023-05-25
Published2023-07-12
Last updated2026-09-13 11:56 UTC
CompanyTeleflex
DistributionUS

Product

Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2097-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.