Stryker Laparoscopic Scissors Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the instructions do not support required sterilization methods, but no injuries or illnesses have been reported.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, HOOK SCISSORS, 29CM (P/N 0250282049). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue 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. The agency has classified this as a Class II recall. The source text does not report any specific injuries, illnesses, or deaths associated with this issue.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 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 w
- 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 · sterilization failure
See all →- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22