Lower riskMedical device recall · FDA · Published December 21, 2020
Hardy Diagnostics Brain Heart Infusion Agar with Vancomycin: Staphylococcus Breakthrough
Hardy Diagnostics recalls Brain Heart Infusion Agar with 6 ug/ml Vancomycin (Lot 472698) due to Staphylococcus aureus breakthrough. Affected users should check their lot numbers and contact the company for details.
“Hardy Diagnostics Brain Heart Infusion Agar with Vancomycin: Staphylococcus Breakthrough.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63629-hardy-diagnostics-brain-heart-infusion-agar-with-vancomycin-staphylococcus-breakthrough. Based on FDA recall #Z-0919-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0919-2021%22&limit=1).
The FDA announced on 2020-12-21 that Hardy Diagnostics is recalling Brain Heart Infusion Agar with Vancomycin due to potential bacterial breakthrough. The agency said the product may fail to inhibit Staphylococcus aureus as intended.
How to tell if you have it
Brand: Hardy Diagnostics
Product: Brain Heart Infusion Agar with 6 ug/ml Vancomycin
Catalog Number: G14
Lot Number: 472698
Manufactured: 2020-10-29
Expires: 2020-12-28
Container Type: 15x100mm plate, 18 ml
UDI Code: 00816576020102
Quantity: 820 units
The hazard
The FDA said complaints reported Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. GovInfoNow's records show no specific incidents or injuries were reported in this recall.
Context
GovInfoNow's records show Hardy Diagnostics has had six other recalls since 2019-11-14. Other recent recalls of similar products include Getinge Thoracic Catheter Recall (2026-08-07), Medline Neuro Sponges Recall (2026-03-19) and Medline VP Shunt Kits recall (2026-03-19).
How to tell if you have this one
Check for the lot number 472698 on the container. The product was manufactured on October 29, 2020, and expired December 28, 2020. It comes in 15x100mm plates with 18 ml of agar.
Brand
Hardy Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number 472698 on the container to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 10 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-0919-2021 (December 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0919-2021 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.