Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a documentation issue regarding sterilization parameters rather than a direct defect causing injury. Per the rubric, documentation issues and packaging-only problems are typically scored as Low (1) or Moderate (2). Given the lack of reported injuries and the nature of the defect being in the instructions rather than the device itself, a score of 1 is appropriate.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY Forceps, Spoon Jaw, P/N 0250080246. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall is due to an error in the Instructions for Use (IFU 1000-401-070 Revision G or prior). The parameters provided in the IFU do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This documentation issue affects the ability to properly sterilize the instruments using these specific methods.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateStingray Surgical Recalls Bipolar Forceps Due to Uncleared Instructions
FDA (Devices) · 2012-07-25
- ModerateStryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling
FDA (Devices) · 2012-07-18
- ModerateStryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2013-05-15
- HighStryker Surgical Forceps Recalled for Incorrect Expiration Date Label
FDA (Devices) · 2023-11-15
- ModerateStryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
FDA (Devices) · 2013-05-15
- ModerateStryker 12-Instrument Sterilization Tray Recalled for Validation Testing Gaps
FDA (Devices) · 2014-05-14