CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report

Sterrad 50 Sterilization System, Product recalled

Advanced Sterilization Products is recalling Sterrad 50 Sterilization System, distributed nationwide in the US. The recall was initiated on 16 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesnot available

Quantity recalled233 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-0745-2014
FDA event ID: 67043
Recalling firm: Advanced Sterilization Products, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 16 Dec 2013
FDA classified: 14 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

16 Dec 2013	Recall initiated by company
14 Jan 2014	Classified by FDA	+29 days
22 Jan 2014	Published in enforcement report	+8 days

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

Reason for recall

Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

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

STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

not available

Where was it sold?

Nationwide Distribution

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 67043

This product is part of a recall event; the main page for the event is Sterrad 100S Sterilization System, Product recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2014	CLASS II	Sterrad 100S Sterilization System, Product recalled	Advanced Sterilization Products	Sterility	Nationwide
22 Jan 2014	CLASS II	Sterrad NX Sterilization System, Product recalled	Advanced Sterilization Products	Sterility	Nationwide

More recalls from Advanced Sterilization Products

All 36

Reported	Class	Recall	Company	Reason	Where
22 Feb 2017Device	CLASS II	Sterrad NX Sterilization System, Product recalled	Advanced Sterilization Products	Sterility	Nationwide
18 Jan 2017Device	CLASS II	Evotech Endoscope Cleaner and Reprocessor System 208V, Product recalled	Advanced Sterilization Products	Sterility	Nationwide
23 Sep 2015Device	CLASS II	Cidex OPA Solution recalled by Advanced Sterilization	Advanced Sterilization Products	Sterility	CA
2 Sep 2015Device	CLASS II	Cidex Activated Dialdehyde Solution/case recalled	Advanced Sterilization Products	Sterility	Nationwide
19 Aug 2015Device	CLASS II	Wall Chart for Sterrad 100NX System recalled by Advanced Sterilization	Advanced Sterilization Products	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,816

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide