Device recall: SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a si
Akita Sumitomo Bakelite Co., Ltd. (Akita) initiated this device recall on 9 Sep 2016; FDA lists 2 product records under event 75388, classified Class II.
FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 10 Nov 2016. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Akita Sumitomo Bakelite Co., Ltd..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Akita Sumitomo Bakelite Co., Ltd., Akita, Japan.
Reason for recall
"Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long"
Distribution
"US in the states of MA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0388-2017 | 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,… | 15 units | Class II | Terminated | 16 Nov 2016 |
| Z-0389-2017 | 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… | 8 units | Class II | Terminated | 16 Nov 2016 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US in the states of MA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Nov 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.