PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 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) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    844120 847649 940155 942772 943443 943715 944091 945723 1040113 1041100 1042487 1042719 1042723 1046398 1142140 1143799 1144239 1144648 1146466 1240951 1242121 1242918 1243800 1244525 1244960 1245118 1246168 1246646 1341534 1341555 1342149 1342766 1343299 1343708 1344297 1440434 1440698 1441383 1441957 1442516 UR20257N
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Stryker Endoscopy
Reason for Recall:
The parameters provided in the Laparoscopic Manual Instruments 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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 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) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

Product Codes/Lot Numbers:

844120 847649 940155 942772 943443 943715 944091 945723 1040113 1041100 1042487 1042719 1042723 1046398 1142140 1143799 1144239 1144648 1146466 1240951 1242121 1242918 1243800 1244525 1244960 1245118 1246168 1246646 1341534 1341555 1342149 1342766 1343299 1343708 1344297 1440434 1440698 1441383 1441957 1442516 UR20257N

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0704-2015

Related Recalls

When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.

Mar 28, 2016 Diagnostic Equipment Nationwide View Details →

Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.

Jun 3, 2015 Implants & Prosthetics Nationwide View Details →

The parameters provided in the Laparoscopic Manual Instruments 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

Nov 17, 2014 Surgical Instruments Nationwide View Details →