Stryker Endoscopy Recalls Babcock Grasper Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of Babcock Grasper Forceps 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. There are no reported injuries or illnesses, and the hazard is related to procedural compliance rather than a direct physical defect causing immediate harm, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the 5mm Insert Babcock Grasper Forceps (P/N 0250080586). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The affected units were distributed worldwide, including in the United States and numerous international markets.
The recall was initiated because the parameters provided in the 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 error means the provided instructions do not accurately reflect the supported sterilization protocols for the device.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PKG, 5MM INSERT, BABCOCK GRASPER FORCEPS, 45CM, P/N 0250080586 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…
- 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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