HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K, P9173R, P9174K, P91795, P91C51, P91C83, P91D30, P91K68, P91L0H, P91K69, P91L0J, P91L1Y, P91L6E, P91L6J, P9396A, P9396C, P9399T, P93A1L, P93M0K, P93M0L, P93N01, P93M5Y, P93N5A, P93N3X, P93N3Y, P93P09, P93P26, P93P7H, P93R10, P93R4F, P93R4G, P93R56, P93R6V, P93T0X, P93T9L, P93T9M, P93U17, P93U91, P93V0V, P93V0W, P93V5T, P93V02, P93V03, P93X4E, P93X65, P93X85, P93X98, P93X9E, P93Y47, P93Y48, P93Y8X, P93X2X, P93Z95, P93Z4T, P93Z5X, P94015, P9405H, P9409W, P9410Z, P9414T, P94A5K, P94A6A, P94C11, P94C47, P94C5R, P94C8T, P94D3J, P94D3K, P94D5G, P94D7Z, P94D9K, P94E1Z, P94E20, P94E3Z, P94E8W, P94F1M, P94F3A, P94F5T, P94F6C, P94F7L, P94G1G, P94G1H, P94G1J, P94H0J, P94H0K, P94H31, P94H4V, P94H8J, P9139V, P91749, P9179U, P91F2X, P91L1Z, P93L47, P93L76, P93M6T, P93M6P, P93N00, P93N7G, P93N7H, P93P2E, P93P7G, P93R0Z, P93R57, P93R6U, P93T20, P93T26, P93U0P, P93U5N, P93U90, P93V57, P93W9X, P93X2G, P93W9R, P93X2W, P94C10, P94D0M, P94D0P, P94J29
- 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:
- The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Product Codes/Lot Numbers:
N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K, P9173R, P9174K, P91795, P91C51, P91C83, P91D30, P91K68, P91L0H, P91K69, P91L0J, P91L1Y, P91L6E, P91L6J, P9396A, P9396C, P9399T, P93A1L, P93M0K, P93M0L, P93N01, P93M5Y, P93N5A, P93N3X, P93N3Y, P93P09, P93P26, P93P7H, P93R10, P93R4F, P93R4G, P93R56, P93R6V, P93T0X, P93T9L, P93T9M, P93U17, P93U91, P93V0V, P93V0W, P93V5T, P93V02, P93V03, P93X4E, P93X65, P93X85, P93X98, P93X9E, P93Y47, P93Y48, P93Y8X, P93X2X, P93Z95, P93Z4T, P93Z5X, P94015, P9405H, P9409W, P9410Z, P9414T, P94A5K, P94A6A, P94C11, P94C47, P94C5R, P94C8T, P94D3J, P94D3K, P94D5G, P94D7Z, P94D9K, P94E1Z, P94E20, P94E3Z, P94E8W, P94F1M, P94F3A, P94F5T, P94F6C, P94F7L, P94G1G, P94G1H, P94G1J, P94H0J, P94H0K, P94H31, P94H4V, P94H8J, P9139V, P91749, P9179U, P91F2X, P91L1Z, P93L47, P93L76, P93M6T, P93M6P, P93N00, P93N7G, P93N7H, P93P2E, P93P7G, P93R0Z, P93R57, P93R6U, P93T20, P93T26, P93U0P, P93U5N, P93U90, P93V57, P93W9X, P93X2G, P93W9R, P93X2W, P94C10, P94D0M, P94D0P, P94J29
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2049-2018
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.