CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Natura Stomahesive Post-Operative / Surgical Ostomy System recalled
ConvaTec is recalling Natura Stomahesive Post-Operative / Surgical Ostomy System, distributed in 12 states. The recall was initiated on 17 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1276-2024
- FDA event ID
- 93896
- Recalling firm
- ConvaTec, Greensboro, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jan 2024
- FDA classified
- 7 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 17 Jan 2024 | Recall initiated by company | |
| 7 Mar 2024 | Classified by FDA | +50 days |
| 13 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Product as listed by the FDA
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Where it was distributed
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.
AlaskaCaliforniaFloridaIllinoisIndianaMichiganNebraskaNew JerseyNew YorkOhioPennsylvaniaTexas
Questions about this recall
Why was it recalled?
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Which lots are affected?
Lot #2C02496, UDI-DI #00768455116096.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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