Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of biopsy 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. The hazard involves incorrect sterilization instructions, which is a significant procedural issue but does not explicitly report injuries or deaths, fitting the Moderate criteria for labeling/instruction errors.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059. The recall is due to an issue with the Instructions for Use (IFU 1000-401-070 Revision G or prior), which do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods.
The affected products are laparoscopic manual instruments intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. These devices are designed to be used endoscopically through cannulae. The recall covers units distributed worldwide, including the United States and numerous international locations.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the recall and proper sterilization protocols.
The recalled product
- Product
- PKG, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059 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
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)
- 940915 941834 941837 945993 1141218 1143469
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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