5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots P4T636 P4T63G P4T689 P4T708 P4T86Z P4T882 P4T89N P4T97L P4T994 P4TA0T P4TA17 P4TA55 P4TA70 P4TA7R P4TC53 P4TC7X P4TC87 P4TC8U P4TC93 P4TD1Y R4003L R40048 R4005Z R4010L R4012F R40142 R4020P R4021H R4027N R4042X R4045N R4046X R4054H
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ethicon Endo-Surgery Inc
- Reason for Recall:
- Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Product Codes/Lot Numbers:
Lots P4T636 P4T63G P4T689 P4T708 P4T86Z P4T882 P4T89N P4T97L P4T994 P4TA0T P4TA17 P4TA55 P4TA70 P4TA7R P4TC53 P4TC7X P4TC87 P4TC8U P4TC93 P4TD1Y R4003L R40048 R4005Z R4010L R4012F R40142 R4020P R4021H R4027N R4042X R4045N R4046X R4054H
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1888-2018
Related Recalls
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Ethicon Endo-Surgery
The devices were shipped unsterilized.
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ethicon Endo-Surgery
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Ethicon Endo Surgery
Identified curing issues with the silicone during the needles manufacturing process.