Akita Sumitomo Bakelite Co., Ltd.: Medical Device Recall in 2016 - (Recall #: Z-0389-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 9, 2016

Date Posted: November 16, 2016

Recall Number: Z-0389-2017

Event ID: 75388

Reason for Recall:

Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type

Status: Terminated

Product Quantity: 8 units

Code Information:

Lot No.: 60564713

Distribution Pattern:

US in the states of MA

Voluntary or Mandated:

Voluntary: Firm initiated