Lower risk Medical device recall · FDA · Published December 27, 2018

Cardinal Health Curity Sponges Not Sterilized - Recall

Cardinal Health recalls non-sterilized Curity All Purpose Sponges (Product Code 8044) due to improper sterilization. These sponges may pose infection risks if used for medical purposes.

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

🇺🇸 FDA recall #Z-0957-2019Medical device Cardinal Health ›

Lower-risk recall

Curity All Purpose Sponges were not sterilized and distributed

Take action

Contact the company

Recalling firmCardinal Health 200, LLC15 Hampshire St Bldg 5 · Mansfield, MA 02048-1113

✎ GovInfoNow plain-language explainer

Cardinal Health is recalling non-sterilized Curity All Purpose Sponges that could lead to infections if used for medical tasks. The recall affects sponges sold between specific dates and models. Read more at govinfonow.com/recall/69201-cardinal-health-curity-sponges-not-sterilized-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/69201-cardinal-health-curity-sponges-not-sterilized-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0957-2019

Cite this page

“Cardinal Health Curity Sponges Not Sterilized - Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69201-cardinal-health-curity-sponges-not-sterilized-recall. Based on FDA recall #Z-0957-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0957-2019%22&limit=1).

Cardinal Health 200, LLC recalled Curity All Purpose Sponges because they were not sterilized, the FDA said on 2018-12-27. Owners should stop using the product immediately.

How to tell if you have it

Brand: Cardinal Health
Product: Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm)
Product Code: 8044
Lot Number: 18E190262
Expiration Date: 05/2023
Quantity: 10,400 units

The hazard

The Curity All Purpose Sponges were not sterilized and distributed. The FDA classified the recall as Class II.

Context

GovInfoNow's records show Cardinal Health 200, LLC has 59 other recalls on record since 2017-06-27. Other recent recalls of similar products include Presource Packs with Microstream Components Risk of Delayed Treatment (2026-08-19), Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (2026-08-18), and Presource Convenience Kits (2026-08-10).

How to tell if you have this one

Check for Product Code 8044 and Lot Number 18E190262 on the sponge packaging. These sponges were sold with an expiration date of May 2023.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for Product Code 8044 and Lot Number 18E190262 on the sponge packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and countries of Canada, Colombia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Dec 27, 2018Firm started the recall
Feb 26, 2019FDA classified it Class II
Mar 6, 2019Published in FDA’s Enforcement Report
Jun 29, 2020FDA terminated the recall

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

Similar recalls

Other Cardinal Health recalls

Latest medical device recalls

Keep exploring

More Cardinal Health recalls

Link to this recall

<a href="https://govinfonow.com/recall/69201-cardinal-health-curity-sponges-not-sterilized-recall">Cardinal Health Curity Sponges Not Sterilized - Recall (GovInfoNow)</a>

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-0957-2019 (December 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0957-2019 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.