Mindray A5 Anesthesia Delivery System
Medical device recall Z-0291-2013. Published in FDA’s Enforcement Report on Nov 28, 2012.
- FDA Class I
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 Nov 28, 2012. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 346 units (311 US - 35 Foreign) 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient’s ventilation.
346 units (311 US - 35 Foreign), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
0631F-01000-00 Various serial numbers 0631F-01000-00 EJ-1A001411 0631F-01000-00 EJ-1A001426 0631F-01000-00 EJ-1A001431 0631F-01000-00 EJ-1A001439 0631F-01000-00 EJ-1A001443 0631F-01000-00 EJ-1C001577 0631F-01000-00 EJ-1C001592…
Every code shown here, 1,997 characters
0631F-01000-00 Various serial numbers 0631F-01000-00 EJ-1A001411 0631F-01000-00 EJ-1A001426 0631F-01000-00 EJ-1A001431 0631F-01000-00 EJ-1A001439 0631F-01000-00 EJ-1A001443 0631F-01000-00 EJ-1C001577 0631F-01000-00 EJ-1C001592 0631F-01000-00 EJ-1C001593 0631F-01000-00 EJ-1C001622 0631F-01000-00 EJ-1A001469 0631F-01000-00 EJ-1A001416 0631F-01000-00 EJ-1A001423 0631F-01000-00 EJ-1B001497 0631F-01000-00 EJ-1B001519 0631F-01000-00 EJ-1B001524 0631F-01000-00 EJ-1B001538 0631F-01000-00 EJ-1B001544 0631F-01000-00 EJ-1B001546 0631F-01000-00 EJ-1B001549 0631F-01000-00 EJ-1B001550 0631F-01000-00 EJ-1C001572 0631F-01000-00 EJ-1C001617 0631F-01000-00 EJ-22001684 0631F-01000-00 EJ-1B001540 0631F-01000-00 EJ-1B001548 0631F-01000-00 EJ-21001634 0631F-01000-00 EJ-21001641 0631F-01000-00 EJ-21001642 0631F-01000-00 EJ-21001644 0631F-01000-00 EJ-21001650 0631F-01000-00 EJ-21001643 0631F-01000-00 EJ-21001654 0631F-01000-00 EJ-22001704 0631F-01000-00 EJ-23001760 0631F-01000-00 EJ-23001765 0631F-01000-00 EJ-23001775 0631F-01000-00 EJ-1A001437 0631F-01000-00 EJ-1A001445 0631F-01000-00 EJ-22001710 0631F-01000-00 EJ-22001724 0631F-01000-00 EJ-22001743 0631F-01000-00 EJ-1A001418 0631F-01000-00 EJ-1B001511 0631F-01000-00 EJ-23001764 0631F-01000-00 EJ-23001768 0631F-01000-00 EJ-23001769 0631F-01000-00 EJ-23001779 0631F-01000-00 EJ-23001792 0631F-01000-00 EJ-22001696 0631F-01000-00 EJ-22001701 0631F-01000-00 EJ-22001705 0631F-01000-00 EJ-22001707 0631F-01000-00 EJ-22001723 0631F-01000-00 EJ-1C001573 0631F-01000-00 EJ-1C001589 0631F-01000-00 EJ-1C001590 0631F-01000-00 EJ-1C001599 0631F-01000-00 EJ-1C001610 0631F-01000-00 EJ-1C001619 0631F-01000-00 EJ-21001667 0631F-01000-00 EJ-22001679 0631F-01000-00 EJ-22001686 0631F-01000-00 EJ-22001688 0631F-01000-00 EJ-22001721 0631F-01000-00 EJ-15001187 0631F-01000-00 EJ-1A001420 0631F-01000-00 EJ-22001699 0631F-01000-00 EJ-1B001512 0631F-01000-00 EJ-1A001459 0631F-01000-00 EJ-21001635 0631F-01000-00 EJ-21001636 0631F-01000-00 EJ-21001637 0631F-01000-00…
FDA’s list runs to 8,434 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.
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 13, 2012.
- FDA classified it on Nov 16, 2012.
- FDA’s Enforcement Report published it on Nov 28, 2012.
- FDA terminated it on Jun 4, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Mindray DS USA, Inc. d.b.a. Mindray North America, of Mahwah, NJ.
- 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 8,434 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
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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.