Stryker Endoscopy Recalls Laparoscopic Biopsy Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic 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 and involves a documentation issue regarding sterilization instructions. Per the rubric, minor labeling or documentation issues and voluntary precautionary recalls are typically rated as Moderate (2).
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM (P/N 0250080580). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall covers units distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, and various nations in Europe, Asia, and South America.
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 issue may affect the proper sterilization of the devices.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 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)
- 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.
See all 207 products in this recall →Related recalls
Same manufacturer · Stryker Endoscopy
See all →- ModerateStryker PneumoSure Insufflators Recalled for Flow Rate Drop
FDA (Devices) · 2016-05-04
- SevereStryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation
FDA (Devices) · 2015-07-01
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
Same hazard · documentation error
See all →- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01