The Recall Desk

FDA (Devices) recall action 75388

Akita Sumitomo Bakelite Co., Ltd. recalled 2 products on 2016-11-16

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-11-16
Critical
0
Units
23

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-11-16

    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.

    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 Oly
    Category
    Distribution
    1 state