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Device recall: STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterili

FDA enforcement event 66317 · Class II · initiated 18 Sep 2013 · status Terminated · terminated 13 Jan 2014

DeviceVoluntary: Firm initiated1 product recordIrvine, CA

Advanced Sterilization Products (Irvine, CA) initiated this device recall on 18 Sep 2013; FDA lists 1 product record under event 66317, 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 13 Jan 2014. 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 (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life."

Distribution

"Nationwide Distribution"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0044-2014	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.	2,995 units	Class II	Terminated	30 Oct 2013

Context

90%of 2013 device events are Class II1,236 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 (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month 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: "Nationwide Distribution"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 Jan 2014. "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.