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Lower risk Medical device recall · FDA · Published November 23, 2020

B Braun APEX Compounding System Control Panel Module Recall: Risk of inaccurate drug

B Braun recalls APEX Compounding System Control Panel Module (AX1000) with software version 1.0.5.57 or earlier. The system may not detect air bubbles exceeding 3% of the ordered volume, risking inaccurate drug compounding.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0718-2021Medical deviceB Braun ›
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Contact the company

Recalling firmB Braun Medical, Inc.1601 Wallace Dr Ste 150 · Carrollton, TX 75006-6690
✎ GovInfoNow plain-language explainer

B Braun is recalling the APEX Compounding System Control Panel Module (product code AX1000) with software version 1.0.5.57 or earlier. This recall is because the system might not alert users to air bubbles larger than 3% of the ordered drug volume, which could lead to compounded drugs that don't meet accuracy requirements. Read more at govinfonow.com/recall/63802-b-braun-apex-compounding-system-control-panel-module-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63802-b-braun-apex-compounding-system-control-panel-module-recall-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0718-2021

Cite this page

“B Braun APEX Compounding System Control Panel Module Recall: Risk of inaccurate drug.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63802-b-braun-apex-compounding-system-control-panel-module-recall-risk. Based on FDA recall #Z-0718-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0718-2021%22&limit=1).

B Braun Medical, Inc. recalled the APEX Compounding System Control Panel Module on Nov. 23, 2020, according to the FDA. The device may fail to alert users to air bubbles exceeding 3% of the ordered volume. This could result in compounded drugs that do not meet specified accuracy ranges.

How to tell if you have it

  • Brand: B Braun
  • Product: APEX Compounding System Control Panel Module
  • REF: 601237
  • Product Code: AX1000
  • Software Version: 1.0.5.57 or earlier
  • Units affected: 85

The hazard

The compounding system has the potential to not immediately interrupt compounding and alert the user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a compounded drug that does not meet the specified accuracy range for an individual ingredient.

Context

GovInfoNow's records show B Braun Medical Inc has 66 other recalls on record since Oct. 15, 2013. Other recent recalls of similar products include B. Braun Medical 100mL Sodium Chloride Injection Recall (Aug. 19, 2026), B. Braun Medical Lactated Ringer's Injection Recall (Aug. 12, 2026), and B Braun Discofix Four Way Stopcock Recall (Aug. 4, 2026). Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), Broselow Domestic Complete ALS Organizer Software Recall (Dec. 15, 2025), and Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026).

How to tell if you have this one

Check for the product code AX1000 with software version 1.0.5.57 or earlier on the control panel module. The system is intended for intravascular drug administration to patients.

  • Brand
    B Braun
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.
Recall numberProduct, codes & lotsQuantity
Z-0717-2021APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.; All APEX Compounding System with Software Version 1.0.5.57 or earlier248 units
Z-0718-2021APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.; All APEX Compounding System with Software Version 1.0.5.57 or earlier85 units
Z-0719-2021APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.; All APEX Compounding System with Software Version 1.0.5.57 or earlier16 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on the control panel module; if it is 1.0.5.57 or earlier, the product is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 26 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Nov 23, 202012. FDA classified it Class II: Dec 23, 202023. Published in FDA’s Enforcement Report: Dec 30, 202034. FDA terminated the recall: Mar 14, 2023420202023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall is for potential inaccuracies in compounded drugs due to air bubble detection issues, but it does not indicate immediate risk of serious injury.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0718-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0718-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA