CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical…
Medical device recall Z-2774-2015. Published in FDA’s Enforcement Report on Sep 23, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 23, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 318,632 cases how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
318,632 cases, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
010713325 010713325 010713324 010713326 010713324 020713327 010713327 010713327 020713327 090713339 020713331 090713339 090713343 090713343 090713345 100713347 110713352 120713353 120713352 100713347 110713352 120713353 150713355 150713356…
Every code shown here, 2,000 characters
010713325 010713325 010713324 010713326 010713324 020713327 010713327 010713327 020713327 090713339 020713331 090713339 090713343 090713343 090713345 100713347 110713352 120713353 120713352 100713347 110713352 120713353 150713355 150713356 150713354 160713360 150713356 150713354 150713354 170713361 170713363 170713362 170713363 170713361 170713364 180713368 190713368 190713369 180713368 190713369 290713370 290713370 050813376 050813377 050813377 050813378 070813384 060813379 050813378 070813384 070813383 070813383 070813385 120813391 120813393 070813385 120813392 120813393 140813399 140813400 140813398 140813399 130813398 190813406 190813408 120813391 130813398 120813394 190813406 200813412 210813414 210813415 210813414 210813413 210813415 230813421 230813422 230813422 270813424 270813420 270813423 270813424 290813430 270813420 140813400 190813407 190813408 290813429 290813432 290813429 290813430 290813431 300813435 290813432 290813433 300813435 210813413 290813431 020913434 020913434 020913438 020913438 040913444 040913445 020913438 040913444 030913442 040913443 040913445 060913450 060913450 090913451 090913451 090913452 110913458 110913457 110913459 110913457 160913466 160913466 160913467 180913472 180913473 160913464 160913467 180913472 180913471 180913473 180913474 230913478 180913474 230913478 230913479 230913479 230913480 240913482 240913482 250913485 260913489 260913488 250913485 250913486 260913488 300913490 300913491 260913489 300913490 100913456 110913458 090913449 090913452 100913456 021013496 021013497 021013497 071013503 021013495 071013503 071013504 071013501 071013504 071013501 091013509 091013510 021013496 141013511 141013514 141013516 091013510 141013514 161013521 161013522 141013511 161013521 161013520 161013522 211013523 211013523 211013528 211013527 211013528 221013530 221013530 231013535 231013533 231013535 231013533 241013536 281013540 281013541 281013539 281013541 241013536 241013538 241013538 241013537 241013538 281013542 281013539 281013542…
FDA’s list runs to 11,163 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 10, 2015.
- FDA classified it on Sep 16, 2015.
- FDA’s Enforcement Report published it on Sep 23, 2015.
- FDA terminated it on May 20, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Advanced Sterilization Products, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 11,163 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.