Covidien Endo Grasp Auto Suture Grasper Recalled for Sterilization Labeling Error
COVIDIEN LLC is recalling 240 units of the Endo Grasp Auto Suture Grasper 5mm because the sterilization method used was not consistent with the labeling and approved method.
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
COVIDIEN LLC is recalling 240 units of the Endo Grasp Auto Suture Grasper 5mm (REF: 173030). The recall was initiated because the sterilization method used for these devices was not consistent with the labeling and the approved sterilization method.
The affected products are identified by lot numbers P8D1335PRX, P8D1336PRX, and P8D1605PRX. These instruments are used in gynecologic, general, urologic, thoracic, and endoscopic procedures for temporary grasping or clamping of tissue and small tubular structures.
The products were distributed worldwide, including nationwide in the United States and to Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland, and Turkey. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubula
- Manufacturer
- COVIDIEN LLC
- Affected units
- 240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by COVIDIEN LLC 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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