Z-0388-2017Class II

SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm

Name: Z-0388-2017 SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm
Creator: Akita Sumitomo Bakelite Co., Ltd.
Published: 2016-09-09
License: https://open.fda.gov/license/

Akita Sumitomo Bakelite Co., Ltd. / initiated 2016-09-09 / Terminated / root cause: labeling and UDI

FDA source

Akita Sumitomo Bakelite Co., Ltd. began a recall of 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... on 2016-09-09. FDA classified it as Class II and gives the reason as "Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0388-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-09
Posted: 2016-11-10
Terminated: 2016-11-10
Recalling firm: Akita Sumitomo Bakelite Co., Ltd.
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.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Sumitomo Bakelite on September 9, 2016 initiated removal of all SB Knife from US accounts. The information was emailed to the accounts and Sumitomo Bakelite requested all customers not to use the mislabeled SB Knife and return product for replacement.
Quantity in commerce: 15 units
Distribution: US in the states of MA
Product codes and lots: Lot No.: 60564711

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0388-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0388-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09
Z-0389-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code KNS

K152771Class IISB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. / cleared 2016-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)