DeviceSignal · Recall classified

Boston Scientific Corporation

FDA classified a device recall on 2026-07-31 · Class II · Z-2840-2026

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 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial…. Recall Z-2840-2026. The firm initiated it on 2026-06-30. This reports the classification FDA published on that date.

Reported facts

Recall number
Z-2840-2026
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 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.

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-2840-2026
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
74c18c6829bde21b94870857bc004f00c34d90569f5df0d43ec324d6101771f5
Signal type
device_recall.classified

Source terms that apply

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Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)