CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report

Sterrad 200, Product recalled by Advanced Sterilization

Advanced Sterilization Products is recalling Sterrad 200, Product. The recall was initiated on 4 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes10200050412 201080057 10200070902 10200080974 10200070758 10200070815 10200070925 201080046 10200070940 10200080949 201080052 10217040349 10200070827 10200040404 10200060693 201080075 10217000008 10217000013 10200070781 10200070824 217060639 200080955 10217050511 10200070782 10200080950 10200060679 10200060682 10200040436 10200070797 10200070844 10217050475 10200060660 10201050501 10200060683 200080996 201080055 10200080984 10200050506 201080040 217060618 10200050508 10200070894 10201060593 10200080976 10200070866 10217000014 10217050496 10200040359 10200050484 10200070791 10200070792 10200070890 10200040365 10200070891 10200050525 10200030329 10200060711 217010092 201080069 10200040379 10200070934 10200060709 10200070839 10200070859 10200060598 10200050519 10200070853 10200040334 217080023 10200070809 201080062 10200060661 10200060702 10200060750 10200070926 10201050524 201080039 201080076 10200070858 10200070892 10200060637 10217050510 10200050533 201080072 217100038 10200060688 200080995 10200080962 10200070897 10200060692 10200060738 201080035 10200070931 10200050536 10200060685 10200040401 10200070755 10217000003 217050373

Quantity recalled19,978 units total (9,792 units in US)

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-0844-2015
FDA event ID: 69692
Recalling firm: Advanced Sterilization Products, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 Nov 2014
FDA classified: 22 Dec 2014
Reported: 31 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

4 Nov 2014	Recall initiated by company
22 Dec 2014	Classified by FDA	+48 days
31 Dec 2014	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

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

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 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Is Sterrad 200, Product recalled?

Yes. Advanced Sterilization Products recalled Sterrad 200, Product on 4 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0844-2015.

Why was it recalled?

Which lots are affected?

10200050412 201080057 10200070902 10200080974 10200070758 10200070815 10200070925 201080046 10200070940 10200080949 201080052 10217040349 10200070827 10200040404 10200060693 201080075 10217000008 10217000013 10200070781 10200070824 217060639 200080955 10217050511 10200070782 10200080950 10200060679 10200060682 10200040436 10200070797 10200070844 10217050475 10200060660 10201050501 10200060683 200080996 201080055 10200080984 10200050506 201080040 217060618 10200050508 10200070894 10201060593 10200080976 10200070866 10217000014 10217050496 10200040359 10200050484 10200070791 10200070792 10200070890 10200040365 10200070891 10200050525 10200030329 10200060711 217010092 201080069 10200040379 10200070934 10200060709 10200070839 10200070859 10200060598 10200050519 10200070853 10200040334 217080023 10200070809 201080062 10200060661 10200060702 10200060750 10200070926 10201050524 201080039 201080076 10200070858 10200070892 10200060637 10217050510 10200050533 201080072 217100038 10200060688 200080995 10200080962 10200070897 10200060692 10200060738 201080035 10200070931 10200050536 10200060685 10200040401 10200070755 10217000003 217050373

Where was it sold?

Worldwide 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 21 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 Advanced Sterilization Products

All 36

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22 Feb 2017Device	CLASS II	Sterrad NX Sterilization System, Product recalled	Advanced Sterilization Products	Sterility	Nationwide
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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	Foreign Material	Nationwide

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