DeviceSignal · Recall classified
ConvaTec, Inc
FDA classified a device recall on 2026-08-19 · Class II · Z-2986-2026
EventRecall classified
Effective2026-08-19
ClassificationClass II
On 2026-08-19 the FDA classified a device recall from ConvaTec, Inc as Class II. Product: Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705…. Recall Z-2986-2026. The firm initiated it on 2026-07-06. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2986-2026
- Classification
- Class II
- Classified on
- 2026-08-19
- Initiated on
- 2026-07-06
- Firm
- ConvaTec, Inc
- Reason
- Urostomy Pouches may leak from cap during use.
- Product
- Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2986-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
7e4d12f424381d6cd4e2e09be36f991697f0ff7bec7c1e487293b5af84b478cb- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)