Stryker Endoscopy Recalls ATRAUMATIC FORCEPS Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of ATRAUMATIC FORCEPS because the provided instructions 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 driven by a documentation issue where the Instructions for Use do not support specific sterilization cycles. There are no reported injuries, illnesses, or deaths, and the hazard is theoretical regarding sterilization validation rather than a direct physical defect causing harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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 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 discrepancy affects the ability to verify proper sterilization for these specific cycles.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. The device does not sustain or support life.
The recalled product
- Product
- PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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)…
- 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.
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