Use caution Medical device recall · FDA · Published June 4, 2020

Cardinal Health NPWT Canister with Gel 300cc Recall: Oversized O-ring Risk

Cardinal Health recalls NPWT Canister with Gel 300cc (model 47-4000) due to potential oversized O-ring causing installation failure. Prescription-only device for wound care.

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

🇺🇸 FDA recall #Z-2543-2020Medical device Cardinal Health ›

Use caution until it’s fixed

Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

Take action

Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337

✎ GovInfoNow plain-language explainer

Cardinal Health is recalling NPWT Canister with Gel 300cc devices that may have an oversized O-ring. This could prevent proper installation, risking device failure during wound care treatment. Read more at govinfonow.com/recall/65040-cardinal-health-npwt-canister-with-gel-300cc-recall-oversized-o.

Source Summary by GovInfoNow · govinfonow.com/recall/65040-cardinal-health-npwt-canister-with-gel-300cc-recall-oversized-o · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2543-2020

Cite this page

“Cardinal Health NPWT Canister with Gel 300cc Recall: Oversized O-ring Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65040-cardinal-health-npwt-canister-with-gel-300cc-recall-oversized-o. Based on FDA recall #Z-2543-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2543-2020%22&limit=1).

Cardinal Health 200, LLC recalled the Cardinal Health NPWT Canister with Gel 300cc due to an oversized O-ring that may prevent proper installation. The Food and Drug Administration announced the Class II recall on June 4, 2020.

How to tell if you have it

Brand: Cardinal Health
Product: Cardinal Health NPWT Canister with Gel 300cc
Model Numbers: 47-4000
Lot numbers: 201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922419, 201922120, 201922121, 201922421
Distribution: US Nationwide and Canada

The hazard

The canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

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), Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (2026-08-18), and Cardinal Health Presource Convenience Kits Recall: Contaminated Applicators Risk Infection (2026-08-10). Other recent recalls of similar products include Olympus HX-400U-30 Ligating Device Recall: Risk of Unintentional Loop Fixation (2025-10-30), Windstone Custom Convenience Kits Pre Op Kit - NS Recall: Backflow Risk (2026-03-11), and Windstone Custom Convenience Kits Pre Op Kit Recall: Backflow Risk (2026-03-11).

How to tell if you have this one

Check for model number 47-4000 on the canister. Lot numbers 201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922419, 201922120, 201922121, 201922421 are affected.

Brand
Cardinal Health
Category
Medical device

FDA recall event · 2 products

All 2 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
Worldwide distribution - US Nationwide distribution and the country of Canada.

Recall number	Product, codes & lots	Quantity
Z-2543-2020	Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.; Model Numbers: 47-4000, Lot numbers:201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922419, 201922120, 201922121, 201922421	3000
Z-2544-2020	Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.; Model Numbers: 48-4000, Lot numbers:201829015, 201923314, 201923316, 201923319, 20192347, 201923414, 201923410.	1960

Based on the official FDA remedy

What to do — step by step

Check Canister Model
Verify the model number is 47-4000 and the lot number is listed in the affected numbers.
Contact Manufacturer
Reach out to Cardinal Health for specific guidance on whether your device needs repair or replacement.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the country of Canada.” 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 5.2 years after the firm started it.

Jun 4, 2020Firm started the recall
Jul 9, 2020FDA classified it Class II
Jul 15, 2020Published in FDA’s Enforcement Report
Aug 5, 2025FDA terminated the recall

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

Similar recalls

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/65040-cardinal-health-npwt-canister-with-gel-300cc-recall-oversized-o">Cardinal Health NPWT Canister with Gel 300cc Recall: Oversized O-ring Risk (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-2543-2020 (June 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2543-2020 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.