CLASS II Device recall · Reported 24 Jul 2013 · FDA Enforcement Report

27023WU Balloon Catheter., 2/pkg, sterile, contains latex recalled

Karl Storz Endoscopy America is recalling 27023WU Balloon Catheter., 2/pkg, sterile, contains latex, distributed in Arizona, Florida, Illinois, Indiana, Texas. The recall was initiated on 31 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.

Quantity recalled40 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-1728-2013
FDA event ID: 65505
Recalling firm: Karl Storz Endoscopy America, Southbridge, MA
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2013
FDA classified: 12 Jul 2013
Reported: 24 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

31 May 2013	Recall initiated by company
12 Jul 2013	Classified by FDA	+42 days
24 Jul 2013	Published in enforcement report	+12 days

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

Reason for recall

Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.

Where it was distributed

US distribution to: AZ, FL, IL, IN and TX.

Arizona Florida Illinois Indiana Texas

Questions about this recall

Why was it recalled?

Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.

Which lots are affected?

Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.

Where was it sold?

US distribution to: AZ, FL, IL, IN and TX.

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.

More recalls from Karl Storz Endoscopy America

All 17

Reported	Class	Recall	Company	Reason	Where
25 Dec 2013Device	CLASS II	Intubation Flexible Fiberscope recalled by Karl Storz Endoscopy America	Karl Storz Endoscopy America	Foreign Material	Nationwide
25 Dec 2013Device	CLASS II	Broncho Flexible Fiberscope recalled by Karl Storz Endoscopy America	Karl Storz Endoscopy America	Foreign Material	Nationwide
18 Dec 2013Device	CLASS II	Axillent Debakey Grasping Forceps recalled	Karl Storz Endoscopy America	Labeling Errors	Nationwide
22 May 2013Device	CLASS II	Electrode, Barrel Bar (27050NX/6) recalled	Karl Storz Endoscopy America	Sterility	Nationwide
22 May 2013Device	CLASS II	Loop, Cutting/6) recalled by Karl Storz Endoscopy America	Karl Storz Endoscopy America	Sterility	Nationwide

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