CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report

StoneBreaker Exhaust Line recalled by Cook

Cook is recalling StoneBreaker Exhaust Line, distributed nationwide in the US. The recall was initiated on 31 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalled760

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-1592-2018
FDA event ID: 79731
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 31 Jan 2018
FDA classified: 2 May 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

31 Jan 2018	Recall initiated by company
2 May 2018	Classified by FDA	+91 days
9 May 2018	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

The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

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

StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006

Where it was distributed

US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, XK, ZA

Nationwide California Colorado Delaware Idaho Illinois Indiana Massachusetts Missouri Puerto Rico

Questions about this recall

Why was it recalled?

The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

Which lots are affected?

All Lots

Where was it sold?

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

6 other products · FDA event 79731

This product is part of a recall event; the main page for the event is StoneBreaker Exhaust Cap recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
9 May 2018	CLASS II	StoneBreaker Exhaust Cap recalled by Cook	Cook	Sterility	Nationwide
9 May 2018	CLASS II	StoneBreaker Single Use Probe recalled by Cook	Cook	Sterility	Nationwide
9 May 2018	CLASS II	StoneBreaker Sterilization Cap recalled by Cook	Cook	Sterility	Nationwide
9 May 2018	CLASS II	StoneBreaker Pneumatic Lithotripter recalled by Cook	Cook	Sterility	Nationwide
9 May 2018	CLASS II	StoneBreaker C02 Cartridge recalled by Cook	Cook	Sterility	Nationwide
9 May 2018	CLASS II	StoneBreaker Probe Cap recalled by Cook	Cook	Sterility	Nationwide

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