Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SB (Sumitomo Bakelite Co. Recalled by Akita Sumitomo Bakelite Co., Ltd. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Akita Sumitomo Bakelite Co., Ltd. directly.
Affected Products
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.
Quantity: 8 units
Why Was This Recalled?
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
Where Was This Sold?
This product was distributed to 1 state: MA
About Akita Sumitomo Bakelite Co., Ltd.
Akita Sumitomo Bakelite Co., Ltd. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report