Sumitomo Bakelite Electrosurgical Knives Recalled for Mislabeled Sterilization Pouches
Akita Sumitomo Bakelite Co., Ltd. is recalling 8 units of electrosurgical knives because their sterilization pouches and cartons were mislabeled as Standard Type instead of Short type.
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, and the hazard is a minor labeling error regarding the product type on the packaging, which fits the criteria for a moderate severity score.
Plain-English summary
Akita Sumitomo Bakelite Co., Ltd. is recalling 8 units of SB (Sumitomo Bakelite Co.,) Electrosurgical Knives. The affected model numbers are MD-47703W, MD-47704, MD-47706, and MD-47703L. These single-use sterile devices are designed to cut tissue within the digestive tract using high-frequency current.
The recall was initiated because the sterilization pouch and carton were mislabeled as Standard Type instead of Short type. The affected units are identified by Lot No. 60564713. The distribution was limited to the United States, specifically in the state of Massachusetts.
Consumers and healthcare facilities should stop using the affected electrosurgical knives and contact the recalling firm for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Akita Sumitomo Bakelite Co., Ltd.
- Hazard
- Affected units
- 8
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.: 60564713
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 →Related recalls
Same manufacturer · Akita Sumitomo Bakelite Co., Ltd.
See all →- ModerateAkita Sumitomo Bakelite Recalls Mislabeled Sterile Electrosurgical Knives
FDA (Devices) · 2016-11-16
Same hazard · mis labeling
See all →- High
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