Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 16, 2016
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.
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Akita Sumitomo Bakelite Co., Ltd. recalled SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. … - a moderate-severity action.
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. … was recalled by Akita Sumitomo Bakelite Co., Ltd. in November 16, 2016. Reason: Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long. Check the official notice for the remedy. Verify recall #Z-0388-2017 with the FDA Devices before acting.
The recall
Akita Sumitomo Bakelite Co., Ltd. issued this moderate-severity FDA Devices recall-Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long.
- Moderate
- severity level
- 15 units
- affected scope
- Class II
- classification
- November 16, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0388-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0388-2017) was formally reported on November 16, 2016, with the manufacturer initiating the action on September 9, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Akita Sumitomo Bakelite Co., Ltd. is listed as the recalling firm, operating out of Akita. Federal records list the affected scope as 15 units.
The documented reason for this recall is: Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long Distribution data in the federal record shows the product reached: US in the states of MA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15 units
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0388-2017 |
| Date reported | November 16, 2016 |
| Date initiated | September 9, 2016 |
| Recalling firm | Akita Sumitomo Bakelite Co., Ltd. |
| Firm location | Akita |
| Affected scope | 15 units |
| Distribution | US in the states of MA |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0388-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akita Sumitomo Bakelite Co., Ltd.. Units affected: 15 units.
Why was this product recalled? ▼
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2016. Severity: Moderate. Recall number: Z-0388-2017.
Where was the recalled product distributed? ▼
Distribution: US in the states of MA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0388-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 16, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.