🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: September 9, 2016 Akita Sumitomo Bakelite Co. Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot No.: 60564711
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Akita Sumitomo Bakelite Co., Ltd.
Reason for Recall:
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Lot No.: 60564711

Distribution:

Distributed in: US, MA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0388-2017

Related Recalls

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.

Akita Sumitomo Bakelite Co.

Class I - Dangerous

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

Sep 9, 2016 Surgical Instruments View Details →