Reported Feb 22, 2017 · Terminated

STERRAD NX Sterilization System, Product Code: 10033, 10033-002

Advanced Sterilization Products

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346

Is this the product you have?

  • STERRAD NX Sterilization System
  • Product Code
    • 10033
    • 10033-002
Lot codes and dates
  • Serial No

    2,996 of 2,996 codes

    • 33100270
    • 33110267
    • 10033070599
    • 33110166
    • 33102348
    • 10033070293
    • 10033070296
    • 10033070115
    • 10033060166
    • 33111764
    • 33120476
    • 10033050564
    • 33130497
    • 10033070381
    • 10033070382
    • 10033060659
    • 33101036
    • 33110266
    • 33110308
    • 33101084
    • 33101087
    • 33120355
    • 33110445
    • 33120379
    • 1033160123
    • 33101078
    • 10033060377
    • 33090564
    • 33081028
    • 33120585
    • 33090532
    • 10033060637
    • 33130516
    • 33110446
    • 33110894
    • 33111832
    • 33111336
    • 33111363
    • 33111573
    • 33111580
    • 33110148
    • 33101330
    • 33120120
    • 10033060898
    • 33100023
    • 33090562
    • 33101545
    • 33101573
    • 33090528
    • 10033070039
    • 10033060706
    • 33100367
    • 10033050651
    • 10033050652
    • 10033050653
    • 10033060178
    • 10033070271
    • 33110891
    • 33120063
    • 33111632
Amount recalled
7,694 units total (5,935 units in US)

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 2, 2017 · Data as of Sep 19, 6:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.