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Lower risk Medical device recall · FDA · Published December 2, 2019

Medela Invia Foam Dressing Kit with FitPad X-Large Recall: Sterile Packaging Holes Risk

Medela recalls Invia Foam Dressing Kit with FitPad X-Large (3 pcs) SKU #0876224 due to potential holes in sterile packaging. This could compromise sterility during medical use. Affected units were sold with specific expiration dates.

🇺🇸 FDA recall #Z-0773-2020Medical deviceMedela ›
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Recalling firmMedela Inc1101 Corporate Dr · McHenry, IL 60050-7006
✎ GovInfoNow plain-language explainer

What happened, in plain English

Medela is recalling Invia Foam Dressing Kit with FitPad X-Large (3 pcs) SKU #0876224 because the sterile packaging might have holes. This could allow contamination during medical procedures, making the dressing unsafe for use. Read more at govinfonow.com/recall/66415-medela-invia-foam-dressing-kit-with-fitpad-x-large-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/66415-medela-invia-foam-dressing-kit-with-fitpad-x-large-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0773-2020

Cite this page

“Medela Invia Foam Dressing Kit with FitPad X-Large Recall: Sterile Packaging Holes Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66415-medela-invia-foam-dressing-kit-with-fitpad-x-large-recall. Based on FDA recall #Z-0773-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0773-2020%22&limit=1).

Why it’s dangerous

The sterile packaging could develop holes, potentially allowing contaminants to enter the dressing. This might compromise the sterility needed for medical procedures, increasing infection risk.

Who’s affected

Healthcare professionals and patients using this dressing kit for medical care. Those with the specific lot numbers and expiration dates listed are most at risk.

How to tell if you have this one

Check for the product name 'Invia Foam Dressing Kit with FitPad - X-Large (3 pcs)' and SKU #0876224. Look for lot numbers: 17110012731 (exp 17-Nov-19), 17110022736 (exp 22-Nov-19), 17120012746 (exp 8-Dec-19), 18010012767 (4-Jan-20), 18070012913 (31-Jul-20), 18090012960 (exp 28-Sep-20), 18110013046 (5-Nov-20).

  • Brand
    Medela
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, SKU, and lot numbers to confirm if your kit is affected.

Where it went and when

Where it was distributed

Distributed in 16 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Minnesota, Missouri, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Washington.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Dec 2, 201912. FDA classified it Class II: Jan 2, 202023. Published in FDA’s Enforcement Report: Jan 8, 202034. FDA terminated the recall: Nov 2, 2020420192020
  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-0773-2020 (December 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0773-2020 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.
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