Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of Endo Metzenbaum Scissors 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 the source text identifies a documentation issue regarding sterilization parameters without reporting any illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The recall covers units distributed worldwide, including the United States and numerous international markets.
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 means the provided instructions do not validate these specific sterilization processes for the device.
Hospitals and healthcare facilities that have received these instruments should stop using them and contact Stryker Endoscopy for further instructions. The device does not sustain or support life.
The recalled product
- Product
- PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. 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) port
- 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 →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02