Covidien: Medical Device Recall in 2021 - (Recall #: Z-1411-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

Product Classification:

Class II

Date Initiated: March 5, 2021

Date Posted: April 21, 2021

Recall Number: Z-1411-2021

Event ID: 87542

Reason for Recall:

Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.

Status: Ongoing

Product Quantity: 59,828 devices

Code Information:

UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900, 20884523000907 UDI-Device Identifier (GTIN/UPN): 10884523000917, 20884523000914

Distribution Pattern:

Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador, Guatemala, Jamaica, Mexico, Panama, Peru, Puerto Rico, Trinidad And Tobago, Austria, Belgium, Bosnia And Herzegovina, Canary Islands, Cyprus, Denmark, Equatorial Guinea, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kosovo, Kuwait, Lebanon, Mauritius, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, Spain, Swaziland, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated