FDA Device recall Z-0388-2017
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm by Akita Sumitomo Bakelite, citing mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0388-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-09 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Akita Sumitomo Bakelite |
| Distribution | MA |
Product
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
Reason
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Identifiers
| code_info | Lot No.: 60564711 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0388-2017%22
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