SB — Class II medical device recall Z-0389-2017
Terminated recall by Akita Sumitomo Bakelite Co., Ltd., reported 2016-11-16. Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
| Recall number | Z-0389-2017 |
|---|---|
| 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 | 8 units |
| Reason classes | labeling |
| Lot numbers | 60564713 |
| Model numbers | MD-47703L, MD-47703W, MD-47704, MD-47706 |
Product
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M 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 labeled as Standard Type instead of Short type
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-0389-2017. 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.