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Lower risk Medical device recall · FDA · Published April 25, 2018

ConvaTec Esteem Synergy Stomahesive: Larger Stoma Hole Risk

ConvaTec recalls Esteem Synergy Stomahesive skin barrier wafers with a larger stoma hole than labeled, which may cause improper fit and discomfort for ostomy users.

🇺🇸 FDA recall #Z-1890-2018Medical deviceConvaTec ›
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Recalling firmConvaTec, Inc7900 Triad Center Dr Ste 400 · Greensboro, NC 27409-9076
✎ GovInfoNow plain-language explainer

ConvaTec is recalling certain Esteem Synergy Stomahesive skin barrier wafers because the stoma hole size may be larger than labeled. This could lead to improper fit and discomfort for people using ostomy systems. Read more at govinfonow.com/recall/71331-convatec-esteem-synergy-stomahesive-larger-stoma-hole-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71331-convatec-esteem-synergy-stomahesive-larger-stoma-hole-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1890-2018

Cite this page

“ConvaTec Esteem Synergy Stomahesive: Larger Stoma Hole Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71331-convatec-esteem-synergy-stomahesive-larger-stoma-hole-risk. Based on FDA recall #Z-1890-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1890-2018%22&limit=1).

ConvaTec, Inc recalled Convatec Esteem(TM) Synergy Stomahesive(R), REF 405475, because the stoma hole may be larger than specified, according to the FDA on April 25, 2018.

How to tell if you have it

  • Brand: ConvaTec
  • Product: Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm
  • REF: 405475
  • Lot Number: 7F00987

The hazard

The stoma hole of one lot of the Esteem synergy Stomahesive Skin Barrier wafers is larger than the 7/8 inch / 22mm specified on the box label, according to the FDA.

Context

GovInfoNow's records show ConvaTec, Inc has had 17 other recalls since Oct. 26, 2017. Other recent recalls of similar products include ConMed Suture Anchor Recall (July 14, 2026), Medtronic DLP Retrograde Cannula (April 21, 2026) and Covidien V-Loc 180 Absorbable Wound Closure Device Recall (June 24, 2026).

How to tell if you have this one

Check for the lot number 7F00987 on the product packaging. The product is the Convatec Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier.

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

What to do — step by step

  1. Check Product Lot Number

    Look for the lot number 7F00987 on the product packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 4.8 years after the firm started it.

1. Firm started the recall: Apr 25, 201812. FDA classified it Class II: May 16, 201823. Published in FDA’s Enforcement Report: May 23, 201834. FDA terminated the recall: Feb 27, 2023420182023
  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-1890-2018 (April 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1890-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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