CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report

Selectsilicone" 100% Silicone Foley Catheter 2-way recalled

Medline Industries is recalling Selectsilicone" 100% Silicone Foley Catheter 2-way, distributed nationwide in the US. The recall was initiated on 28 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 40884389034416 Model DYND11552 lot 287181201.

Quantity recalled330

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-2042-2020
FDA event ID: 84791
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2019
FDA classified: 18 May 2020
Reported: 27 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

28 May 2019	Recall initiated by company
18 May 2020	Classified by FDA	+356 days
27 May 2020	Published in enforcement report	+9 days

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

Reason for recall

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

Product as listed by the FDA

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.

Where it was distributed

US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

Nationwide Colorado Illinois Kentucky Missouri New Jersey Oregon Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

Which lots are affected?

GTIN 40884389034416 Model DYND11552 lot 287181201.

Where was it sold?

US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

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 84791

This product is part of a recall event; the main page for the event is Selectsilicone" 100% Silicone Foley Catheter 2-way recalled.

Reported	Class	Recall	Company	Reason	Where
27 May 2020	CLASS II	Selectsilicone" 100% Silicone Foley Catheter 2-way recalled	Medline Industries	Particulate Matter	Nationwide
27 May 2020	CLASS II	Selectsilicone" 100% Silicone Foley Catheter 2-way recalled	Medline Industries	Particulate Matter	Nationwide

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