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Device recall: STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers u

FDA enforcement event 63877 · Class II · initiated 20 Sep 2012 · status Terminated · terminated 17 Oct 2013

DeviceVoluntary: Firm initiated1 product recordIrvine, CA

Advanced Sterilization Products (Irvine, CA) initiated this device recall on 20 Sep 2012; FDA lists 1 product record under event 63877, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 17 Oct 2013. Initiation: voluntary: firm initiated. Advanced Sterilization Products has 26 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Advanced Sterilization Products, Irvine, CA.

Reason for recall

"Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life."

Distribution

"Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0661-2013	STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only…	12,280 units	Class II	Terminated	16 Jan 2013

Context

88%of 2012 device events are Class II823 events that year

1product record in this eventfirm median: 1

26events on this register for the firm

Other enforcement events for Advanced Sterilization Products

Initiated	Product (first record)	Type	Class	Records
9 Jan 2017	STERRAD NX Sterilization System, Product Code: 10033, 10033-002	Device	Class II	1
27 Sep 2016	EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reproce	Device	Class II	1
10 Aug 2015	CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.	Device	Class II	1
27 Jul 2015	CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266	Device	Class II	1
17 Jul 2015	Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal	Device	Class II	1
11 May 2015	EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor	Device	Class II	2
24 Dec 2014	Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425	Device	Class II	1
4 Nov 2014	STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperatur	Device	Class II	5
16 Dec 2013	STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low tempe	Device	Class II	3
26 Nov 2013	STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monito	Device	Class II	1

All 26 events for Advanced Sterilization Products

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Oct 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.