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Lower risk Medical device recall · FDA · Published October 22, 2018

BD BBL Trypticase Soy Agar Recall: Inhibited Gram Negative Growth Risk

Becton Dickinson recalls BD BBL Trypticase Soy Agar with 5% Sheep Blood (Lot 8221508) due to inhibited growth of Gram negative bacteria. Affected users should contact for remedy.

🇺🇸 FDA recall #Z-0528-2019Medical deviceBecton Dickinson ›
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Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212
✎ GovInfoNow plain-language explainer

What happened, in plain English

Becton Dickinson is recalling a specific lot of BD BBL Trypticase Soy Agar with 5% Sheep Blood because it may not grow certain bacteria properly. This could affect lab results if used in testing. The recall is for a single lot, not all products. Read more at govinfonow.com/recall/69566-bd-bbl-trypticase-soy-agar-recall-inhibited-gram-negative-growth.

Source Summary by GovInfoNow · govinfonow.com/recall/69566-bd-bbl-trypticase-soy-agar-recall-inhibited-gram-negative-growth · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0528-2019

Cite this page

“BD BBL Trypticase Soy Agar Recall: Inhibited Gram Negative Growth Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69566-bd-bbl-trypticase-soy-agar-recall-inhibited-gram-negative-growth. Based on FDA recall #Z-0528-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0528-2019%22&limit=1).

Why it’s dangerous

The product was made incorrectly in one lot, which means it might not grow Gram negative bacteria as it should. This could lead to inaccurate lab results if used in testing. However, the issue only affects one specific lot, not the entire product line.

Who’s affected

Lab users who purchased the specific lot (8221508) from the manufacturer. Those using this agar for bacterial culture testing are most at risk.

How to tell if you have this one

Check for the lot number 8221508 on the packaging. The product is labeled as BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261. It expired on November 30, 2018.

  • Brand
    Becton Dickinson
  • Product
    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 8221508 on the packaging to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 25 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Hawaii, Maryland, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas, Vermont, Virginia, Washington, West Virginia.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Oct 22, 201812. FDA classified it Class II: Nov 30, 201823. Published in FDA’s Enforcement Report: Dec 12, 201834. FDA terminated the recall: Apr 3, 2020420182020
  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.

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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-0528-2019 (October 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0528-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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