FDA Medical devices recall · January 22, 2025

8MM,MEGA NEEDLE DRIVER,IS4000¿ recall

Read the official FDA notice ↗

Product

8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194

Why was it recalled?

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model Number: 470194 Part Number: 470194-06 UDI-DI code: 00886874112342 Batch Numbers: K10221113 K10221128 K10221204 K10221212 K10221218 K10230112 K10230205 K10230212 K10230217 K10230824 K10240418 K10240502 K10240523 K10240718 K10240801 K11221212 K11230112 K11230217 K11240418 K12230112 K12230217 K16240702 U10230217 Model Number: 470194 Part Number: 470194-08 UDI-DI code: 00886874112342 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230405 K10230420 K10230511 K10230525 K10230601 K10230608 K10230615 K10230622 K10230706 K10230713 K10230720 K10230727 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231214 K10240104 K10240111 K10240118 K10240125 K10240202 K10240208 K10240215 K10240314 K10240327 K10240404 K10240425 K10240509 K10240515 K10240523 K10240606 K10240613 K10240620 K10240627 K10240702 K10240822 K11230302 K11230310 K11230323 K11230720 K11230727 K11230914 K11231012 K11231027 K11231109 K11240118 K11240125 K11240314 K11240404 K11240509 K11240620 K11240822 K12230302 K12230914 K12240404 K12240509 K12240620 U10230517

Distribution

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0858-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.