Stryker Johann Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where the instructions do not support specific sterilization methods, but no injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery.
The recall was initiated because the parameters provided in the Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
Distribution
Part of a larger recall action
This product is one of 207 recalled by Stryker Endoscopy 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.
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