Stryker Johann Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.
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, but the source text identifies a documentation error (Instructions for Use) regarding sterilization parameters without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving labeling/documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, 5MM X 33CM INSERT, JOHANN FORCEPS (P/N 0250080763). The recall was initiated because the parameters provided in the Laparoscopic Manual Instruments 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 affected instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, the United Kingdom, Germany, and Japan.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- PKG, 5MM X 33CM INSERT, JOHANN FORCEPS, P/N 0Laparoscopic 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 which…
- 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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