SB Knife -Electrosurgical Knife — Class II medical device recall Z-0388-2017
Terminated recall by Akita Sumitomo Bakelite Co., Ltd., reported 2016-11-16. Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
| Recall number | Z-0388-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akita Sumitomo Bakelite Co., Ltd., Akita, Japan |
| Recall initiated | 2016-09-09 |
| Classified | 2016-11-09 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2016-11-10 |
| Quantity | 15 units |
| Reason classes | labeling |
| Lot numbers | 60564711 |
| Model numbers | MD-47703L, MD-47703W, MD-47704, MD-47706 |
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 for recall
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0388-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.