DeviceSignal · Recall classified
Boston Scientific Corporation
FDA classified a device recall on 2026-07-31 · Class II · Z-2838-2026
EventRecall classified
Effective2026-07-31
ClassificationClass II
On 2026-07-31 the FDA classified a device recall from Boston Scientific Corporation as Class II. Product: Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN…. Recall Z-2838-2026. The firm initiated it on 2026-06-30. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2838-2026
- Classification
- Class II
- Classified on
- 2026-07-31
- Initiated on
- 2026-06-30
- Firm
- Boston Scientific Corporation
- Reason
- Potential for breach in sterile barrier of device packaging.
- Product
- Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
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-2838-2026- 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
ffb081c0c6b229e2d23eeff5e1291e88b8740c4406c0477f8b82efd5b46027dd- 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)