Stryker Endoscopy Recalls 3mm Biopsy Punch Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of 3mm Biopsy Punch instruments 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 the issue as a documentation/labeling error regarding sterilization parameters rather than a reported injury or structural defect, fitting the 'Minor labeling errors' criterion for a Moderate score.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, BIOPSY PUNCH, 20CM (P/N 0250282013) laparoscopic manual instruments. These devices are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery.
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. This documentation discrepancy affects the ability to verify proper sterilization for these specific cycles.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare facilities and distributors should stop using these specific instruments and contact Stryker Endoscopy for further instructions on the recall process.
The recalled product
- Product
- PKG, 3MM INSERT, BIOPSY PUNCH, 20CM, P/N 0250282013 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)
- 442727 1142557 1342138
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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