Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0388-2017·Announced 2016-11-16

Akita Sumitomo Bakelite Recalls Mislabeled Sterile Electrosurgical Knives

Akita Sumitomo Bakelite Co., Ltd. is recalling 15 units of sterile electrosurgical knives that were mislabeled as Standard type instead of Jr type-Long.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is a labeling error regarding the device type, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.

Plain-English summary

Akita Sumitomo Bakelite Co., Ltd. is recalling 15 units of the SB Knife, a sterile electrosurgical knife. The affected devices are single-use and designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators to cut tissue within the digestive tract using high-frequency current.

The recall is due to a labeling error where the sterilization pouch and carton box were labeled as Standard type instead of Jr type-Long. The specific model numbers involved are MD-47703W, MD-47704, MD-47706, and MD-47703L. The affected units are identified by Lot No. 60564711.

The recalled products were distributed in the United States in the state of Massachusetts. Consumers and healthcare providers should stop using these specific units and contact the recalling firm for instructions on return or replacement.

The recalled product

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…
Manufacturer: Akita Sumitomo Bakelite Co., Ltd.
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling
Affected units: 15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot No.: 60564711

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Akita Sumitomo Bakelite Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Akita Sumitomo Bakelite Co., Ltd.

See all →

Moderate
Sumitomo Bakelite Electrosurgical Knives Recalled for Mislabeled Sterilization Pouches
FDA (Devices) · 2016-11-16

Same hazard · mis labeling