CLASS II Device recall · Reported 16 Nov 2016 · FDA Enforcement Report

SB Knife -Electrosurgical Knife, Sterile Size recalled

Akita Sumitomo Bakelite is recalling SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD, distributed in Massachusetts. The recall was initiated on 9 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No.: 60564711

Quantity recalled15 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0388-2017
FDA event ID: 75388
Recalling firm: Akita Sumitomo Bakelite, Akita
Classification: Class II
Status: Terminated
Recall initiated: 9 Sep 2016
FDA classified: 9 Nov 2016
Reported: 16 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

9 Sep 2016	Recall initiated by company
9 Nov 2016	Classified by FDA	+61 days
16 Nov 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long

Product as listed by the FDA

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.

Where it was distributed

US in the states of MA

Massachusetts

Questions about this recall

Why was it recalled?

Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long

Which lots are affected?

Lot No.: 60564711

Where was it sold?

US in the states of MA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 75388

This product is part of a recall event; the main page for the event is SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size recalled.

Reported	Class	Recall	Company	Reason	Where
16 Nov 2016	CLASS II	SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size recalled	Akita Sumitomo Bakelite	Labeling Errors	MA

More recalls from Akita Sumitomo Bakelite

All 2

Reported	Class	Recall	Company	Reason	Where
16 Nov 2016Device	CLASS II	SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size recalled	Akita Sumitomo Bakelite	Labeling Errors	MA

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