Stryker Blakesly Biopsy Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Blakesly Biopsy Forceps because the instructions for use do not support specific sterilization methods.
What this means for you
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The issue is a documentation error regarding sterilization parameters rather than a direct structural defect or reported injury.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of Blakesly Biopsy Forceps, Spoon w/Pin (P/N 0250080293). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgical procedures.
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 device is distributed worldwide, including nationwide in the United States and internationally to numerous countries.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. 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) p
- 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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