Macan Engineering and Manufacturing Co., Inc. Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000
Brand
Macan Engineering and Manufacturing Co., Inc.
Lot Codes / Batch Numbers
Model MC-4A, serial numbers 7001 to 7456
Products Sold
Model MC-4A, serial numbers 7001 to 7456
Macan Engineering and Manufacturing Co., Inc. is recalling Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Dame due to The product label fails to warn users to use the device on patients with shielded pacemakers only.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product label fails to warn users to use the device on patients with shielded pacemakers only.
Recommended Action
Per FDA guidance
Product recall letters dated 4/5/06 were sent to the distributors, along with recall packages dated 3/23/06, to be sent out to their customers who purchased a MC-4A instrument. The recall packages consist of a customer letter dated 3/23/06, a new warning label - part number 4ALB-001, installation instructions for the label placement, a customer response sheet, and a self-addressed stamped return envelope for the response sheet. The customer letter informs the customers that the old device label lacked adequate information regarding the use of the instrument on patients with pacemakers, and requesting that they place the enclosed label with the required warnings on the device, and complete and return the response sheet.
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 noticePage updated: Jan 10, 2026