Stryker Endoscopy Recalls 180,573 Alligator Graspers Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 3mm Alligator Graspers 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a documentation/instructional issue regarding sterilization parameters, which aligns with the 'Moderate' criteria for minor labeling or documentation errors without reported harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM (P/N 0250282004). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall is classified as Class II by the FDA.
The recall is being issued 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. The devices are distributed worldwide, including nationwide in the USA and internationally to numerous countries.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. The specific lot codes associated with this recall are 746665, 747489, 841837, 847462, 943678, 1041060, 1042953, 1043059, 1046383, 1341551, 1341979, and 1343418.
The recalled product
- Product
- PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 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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