Sterilmed Inc Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired.
Brand
Sterilmed Inc
Lot Codes / Batch Numbers
n/a
Products Sold
n/a
Sterilmed Inc is recalling Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and due to SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being condu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Recommended Action
Per FDA guidance
Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, MA, MI, MN, MS, MO, MT, NE, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WV, WI
Page updated: Jan 10, 2026