EM Innovations Inc Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.
Brand
EM Innovations Inc
Lot Codes / Batch Numbers
The recalled units are identified with the Lot Codes: 070505 and 110602.
Products Sold
The recalled units are identified with the Lot Codes: 070505 and 110602.
EM Innovations Inc is recalling Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick- due to The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.
Recommended Action
Per FDA guidance
The recalling firm contacted all fifteen (15) of its distributor/customers (not just the distributors that received the affected devices) via telephone on 4/3-5/2006 in order to inform them that the User Instructions had not been included with the needle containment devices that were shipped between 7/5/2005 and 4/3/2006. The firm asked that the distributors check their inventories and if it was determined that User Instructions were missing, report the amount needed to the recalling firm which would in turn send them out. The firm followed up on their recall action via telephone on 7/11/2006, at which time, it was determined that that all of the distributors either had old User Instructions in stock for distribution, or that there were no affected device units left in inventory.
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
IN, MO, NJ, OH, PA, WI
Page updated: Jan 10, 2026