Stryker Endoscopy Recalls Maryland Dissecting Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Maryland Dissecting Forceps units 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/instruction error regarding sterilization parameters rather than a direct defect causing reported injuries or hospitalizations, fitting the Moderate criteria for minor labeling or documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of Maryland Dissecting Forceps (5mm insert, curved left, 45cm, P/N 00250080578). 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 recall covers units distributed worldwide, including the United States and numerous international locations such as Canada, the United Kingdom, Germany, and Japan.
Healthcare providers and facilities should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the recall and replacement of the devices.
The recalled product
- Product
- PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 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…
- 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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