FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
- Recall number
- Z-1481-04
- Recalling firm
- Advanced Sterilization Products
- Product
- Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
- Status
- Terminated
- Initiated
- 2003-09-04
- Posted
- 2004-09-21
- Terminated
- 2005-01-04
- Reason
- Performance failure complaints.
- Root cause
- Other
- Action
- Firm issued a Safety Alert to inform users to perform a daily Quality Control check of the test strips to ensure that they are working.
- Quantity
- 95783 cases
- Distribution
- Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.
- Lot, serial or model codes
- CIDEX OPA code 20392, lots: 9272, 9273, 9433, 9434, 9436, 9461, 9512, 9513, 9537, 9538, 9578, 9593, 9664, 9699, 9743, 9744, 9745, 9746, 9814, 9815, 9816, 9854, 9935, 9984, 9985, 10019, 10028, 10036, 10037, 8101, 8144, 8218, 8233, 8321, 8482, 8483, 8510, 8511, 8512, 8513, 8514, 8618, 8630, 8631, 8632, 8636, 8637, 8638, 8792, 8793, 8794, 8795, 8796, 8797, 8798, 8978, 8980, 8981, 9130, 9131, 9133, 9270, 9271, 9272 CIDEX OPA code 20393, lots: 8079, 8102, 8219, 8223, 8421, 8456, 8515, 8550, 8633, 8639, 8970, 8982, 9075, 9260, 9274, 9275, 9536, 9564, 9663, 9796, 9907, 9908, 10000
- 510(k) numbers
- K991709
- PMA numbers
- not on file
- Product code
- JOJ
- 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