FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
- Recall number
- Z-2459-2015
- Recalling firm
- Advanced Sterilization Products
- Product
- CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
- Status
- Terminated
- Initiated
- 2015-07-27
- Posted
- 2015-08-25
- Terminated
- 2016-07-06
- Reason
- Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.
- Root cause
- Device Design
- Action
- A Urgent Product Notification Letter dated July 27, 2015, will be sent to customers and distributor who purchased the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24 month shelf life. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers with questions or need additional packing labels are instructed to contact Stericycle at (877) 550-0701, M-F, 8am-5pm ET. Customers are instructed to report complaints or suspected problems with CIDEX Activated Dialdehyde Solution by contacting (888) 783-7723.
- Quantity
- 23,426 cases
- Distribution
- US (nationwide) Distribution
- Lot, serial or model codes
- 210813065 210813066 220813066 230813067 270813067 270813068 270813069 280813069 280813070 290813070 021013082 031013082 031013083 031013084 041013084 071013084 071013085 111013090 111013091 141013091 231013091 241013091 241013092 281013093 060114109 070114109 290114001 300114001 300114002 100214003 100214004 110214004 130214004 010414020 010414021 250314017 260314017 260314018 270314018 270314019 310314019 310314020 070514029 120514029 120514030 130514030 140514030 010714048 300614047 020714048 020714049 030714049 090914066 100914066 110914066 110914067 150914067 160914068 170914068 170914069 021014077 231014084 231014085 271014085 271014086 281014086 201114092 211114092 091214099 091214100 150115006 160115006 220115006 220115007 230115007 100215012 110215012 110215013 050515029 050515030 060515030 070515031
- 510(k) numbers
- ["K060618"]
- PMA numbers
- not on file
- Product code
- MED
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28