Stryker Endoscopy Recalls Biopsy Punch Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 biopsy punch instruments 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 and involves a labeling error regarding sterilization parameters. There are no reported injuries or illnesses, and the hazard is related to documentation and process support rather than a direct defect causing immediate harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, BIOPSY PUNCH, 29CM (P/N 0250282060). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue during surgical procedures. The recall is classified as Class II by the FDA.
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. This labeling discrepancy may affect the proper sterilization of the devices.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. 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, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 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 wh
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 442728 1142559 1146667
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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