STERRAD 50, Product Code 10114 recallZ-0842-2015 · Advanced Sterilization Products · initiated Nov 4, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Sterilization Products or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
A customer notification letter dated 11/21/2014 will be sent to all customers who purchased the STERRAD 50, STERRAD 100S, STERRAD 200, STERRAD 100NX, and STERRAD NX System Cassettes. The letter informs the customers of the problems identified and the actions to be taken.
Recall details
- Recall number
- Z-0842-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 4, 2014
- Posted by the FDA
- Dec 22, 2014
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 19,978 units total (9,792 units in US)
- Product code
- FLF
- FDA submissions
- K023290
- Distribution
- Worldwide Distribution.
Product description
STERRAD 50, Product Code 10114. 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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
10050056174 10050021097 10050035006 10050035054 10050021012 10050035378 10050056170 10050035179 10050021050 10050035261 10050035388 10050021110 10050045549 10050035374 10050035338 10050045503 10050045613 10050035156 10050021060 10050000834 10050035172 10050035181 10050045569 10050035323 10050056188 10050056115 10050035141 10050000517 10050035284 10050045451 10050045404 10050021041 10050021111 10050000850 10050045478 10050010941 10050045603 10050056205 10050035392 10050000762 10050045429 10050000680 10050045491 10050056194 10050021049 10050000867 10050035173 10050056134 10050035387 10050056168 10050021149 10050035013 10050035159 10050035137 10050035100 10050035002 10050035121 10050056203 10050010945 10050010948 10050035287 10050045477 10050056165 10050045507 10050021032 10050035267 10050000712 10050045576 10050035061 10050045563 10050021145 10050045612 10050035143 10050035375 10050035174 10050045557 10050035188 10050021037 10050035330 10050056109 10050056116 10050021116 10050056166 10050000552 10050045494 10050056175 10050045614 10050021077 10050000554 10050021054 10050056145 10050000872 10050000532 10050000621 10050056138 10050056154 10050010952 10050035066 10050000858 10050035337
Other devices under the same FDA submission
2 devices cleared under K023290 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sterrad 10101Advanced Sterilization Products Services Inc. · Sterilizer, ethylene-oxide gas258 reports
- STERRAD™ 10113Advanced Sterilization Products Services Inc. · Sterilizer, chemical2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 69692).
- Z-0843-2015 · TerminatedSTERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and m…
- Z-0845-2015 · TerminatedSTERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and mois…
- Z-0846-2015 · TerminatedSTERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and m…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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