PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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: 44411 140587 641149 644759 743486 744853 840512 840696 846768 847022 940075 940789 941063 942138 943425 943746 944668 944833 945446 1040593 1040936 1041993 1042655 1042656 1042657 1142000 1142622 1142919 1143080 1143700 1143975 1144397 1144619 1144992 1146362 1240537 1241178 1241457 1243803 1244170 1244532 1245025 1245026 1341526 1341994 1342762 1344294 1344877 1440444 1442629 1443580 645726
- 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, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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:
44411 140587 641149 644759 743486 744853 840512 840696 846768 847022 940075 940789 941063 942138 943425 943746 944668 944833 945446 1040593 1040936 1041993 1042655 1042656 1042657 1142000 1142622 1142919 1143080 1143700 1143975 1144397 1144619 1144992 1146362 1240537 1241178 1241457 1243803 1244170 1244532 1245025 1245026 1341526 1341994 1342762 1344294 1344877 1440444 1442629 1443580 645726
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0650-2015
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