Stryker Kelly Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Kelly Forceps units 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 hazard is a documentation issue regarding sterilization instructions rather than a direct defect causing injury, fitting the Moderate severity criteria for labeling/documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, KELLY FORCEPS, CURVED LEFT (P/N 0250080283). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The devices are distributed worldwide, including in the United States and numerous international locations.
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 instruments.
Healthcare facilities and distributors should stop using the affected units and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. 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 whic
- 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 issue
See all →- LowBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa 350010 series recalled for lacking unique device identifier
FDA (Devices) · 2026-03-18
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18