Cardiocommand Inc. TAPSYSTEM Model 2A, REF 8002A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TAPSYSTEM Model 2A, REF 8002A
Brand
Cardiocommand Inc.
Lot Codes / Batch Numbers
SERIAL NUMBERS: 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A.
Products Sold
SERIAL NUMBERS: 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A.
Cardiocommand Inc. is recalling TAPSYSTEM Model 2A, REF 8002A due to There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
Recommended Action
Per FDA guidance
On June 24, the firm plans to send URGENT MEDICAL DEVICE letters to six consignees that will advise them of the issue, request that they either return their device or perform an ON/OFF switch verification procedure, and to return the attached REPLY FORM.
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