Stryker Endoscopy Recalls 5mm Metzenbaum Scissors Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm Metzenbaum Scissors 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 and involves a documentation/labeling error regarding sterilization methods. The source text does not report any illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM (P/N 0250080575). The recall is due to a documentation issue where 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.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, Germany, and Japan. The recall is classified as Class II by the FDA.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 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…
- 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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateStryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2013-05-15
- HighSklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
FDA (Devices) · 2025-01-22
- ModerateStryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
FDA (Devices) · 2013-05-15
- ModerateStryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling
FDA (Devices) · 2012-07-18
- ModerateStryker Irrigator Tips Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2013-05-15
- HighIntegra York Metzenbaum Scissors Recalled Due to Packaging Seal Separation
FDA (Devices) · 2016-12-21