PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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 - DangerousWhat Should You Do?
- Check if you have this product: 140616 245976 340614 344497 444951 540952 643595 846782 847704 940162 941321 942551 943424 943445 943536 943537 945451 1040934 1041474 1041845 1042234 1042681 1042691 1042707 1141159 1141977 1143134 1144330 1145150 1145799 1146352 1240419 1240501 1241813 1242394 1242476 1243369 1244536 1245518 1341465 1341598 1341600 1343695 1344290 1345041 1345100 1345606 1346109 1346670 1440677 1440707 1440894 1440896
- 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:
- 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, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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:
140616 245976 340614 344497 444951 540952 643595 846782 847704 940162 941321 942551 943424 943445 943536 943537 945451 1040934 1041474 1041845 1042234 1042681 1042691 1042707 1141159 1141977 1143134 1144330 1145150 1145799 1146352 1240419 1240501 1241813 1242394 1242476 1243369 1244536 1245518 1341465 1341598 1341600 1343695 1344290 1345041 1345100 1345606 1346109 1346670 1440677 1440707 1440894 1440896
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0634-2015
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.
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.
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