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Lower risk Medical device recall · FDA · Published January 17, 2024

ConvaTec Natura Stomahesive Ostomy Kit: 45mm vs 57mm Coupling Ring Mismatch

ConvaTec recalls a specific ostomy kit due to a mismatched coupling ring size (45mm vs 57mm) that could cause improper fitting.

🇺🇸 FDA recall #Z-1276-2024Medical deviceConvaTec ›
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Recalling firmConvaTec, Inc7815 National Service Rd Ste 600 · Greensboro, NC 27409-9403
✎ GovInfoNow plain-language explainer

ConvaTec is recalling a specific surgical ostomy kit because the pouch is designed for a 57mm coupling ring, but the kit includes a 45mm ring. This mismatch could lead to improper use and potential complications. Read more at govinfonow.com/recall/56308-convatec-natura-stomahesive-ostomy-kit-45mm-vs-57mm-coupling-ring.

Source Summary by GovInfoNow · govinfonow.com/recall/56308-convatec-natura-stomahesive-ostomy-kit-45mm-vs-57mm-coupling-ring · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1276-2024

Cite this page

“ConvaTec Natura Stomahesive Ostomy Kit: 45mm vs 57mm Coupling Ring Mismatch.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56308-convatec-natura-stomahesive-ostomy-kit-45mm-vs-57mm-coupling-ring. Based on FDA recall #Z-1276-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1276-2024%22&limit=1).

ConvaTec, Inc. recalled the ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System on Jan. 17, 2024, according to the FDA. The hazard is that the kit contains a flange with a 45mm coupling ring while the pouch is for a 57mm coupling ring.

How to tell if you have it

  • Brand: ConvaTec
  • Product: ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System
  • REF: 416938
  • Size: 1 3/4 in. 45mm, Sterile
  • Lot #: 2C02496
  • UDI-DI: #00768455116096

The hazard

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

Context

GovInfoNow's records show ConvaTec, Inc. has 17 other recalls on record since Oct. 26, 2017. Other recent recalls of similar products include ConvaTec Esteem Body Soft Urostomy Pouches May Leak During Use (July 6, 2026), ConvaTec Aquacel Ag Surgical SP Dressings Recalled Due to Manufacturing Defect (June 8, 2026), and ConvaT: EsteemBody Drainable Pouch Leak Recall - Manufacturing Issue (Feb. 16, 2026).

How to tell if you have this one

Check for the product reference number REF 416938 on the kit. The kit includes a 45mm coupling ring, but the pouch is intended for a 57mm ring.

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

What to do — step by step

  1. Check Product Details

    Verify the product reference number REF 416938 and the coupling ring size (45mm) on the kit.

Where it went and when

Where it was distributed

Distributed in 12 states, and outside the U.S.

Alaska: yesAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, California, Florida, Illinois, Indiana, Michigan, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas.

Recall timeline

FDA published this recall 56 days after the firm started it.

1. Firm started the recall: Jan 17, 202412. FDA classified it Class II: Mar 7, 202423. Published in FDA’s Enforcement Report: Mar 13, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1276-2024 (January 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1276-2024 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