Covidien Procedure Kits Recalled for Sterilization Labeling Inconsistency
Covidien LLC is recalling 148 procedure kits 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific issue is a labeling/sterilization inconsistency without reported injuries, fitting the Moderate category for low-risk contamination or labeling errors.
Plain-English summary
Covidien LLC is recalling 148 units of surgical procedure kits, including various laparoscopic and general surgery kits, due to a sterilization discrepancy. The recall was initiated because the sterilization method used for these devices was not consistent with the product labeling and the approved sterilization method.
The affected products include 12 specific kit types, such as the BOX KIT00529H, BOX KIT00680, and BOX KIT00681, among others. These kits contain the Covidien Endo Grasp Auto Suture grasper, a 5 mm instrument used for temporary grasping and clamping of tissue in gynecologic, general, urologic, thoracic, and endoscopic procedures.
The affected lots were distributed worldwide, including in the United States (nationwide), Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland, and Turkey. Users should check their inventory for the specific lot numbers listed in the official recall notice and contact the manufacturer for instructions on how to return or replace the affected units.
The recalled product
- Product
- Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6
- Manufacturer
- COVIDIEN LLC
- Affected units
- 148
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 (2)
- 0217119259 (7)KIT00599 LAPARO GENERICO X1 Lot Numbers: 0217130753
- 0217119259 (7)KIT00599 LAPARO GENERICO X1 0217130753
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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