Custom Ultrasonics, Inc. 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
Brand
Custom Ultrasonics, Inc.
Lot Codes / Batch Numbers
Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
Products Sold
Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
Custom Ultrasonics, Inc. is recalling 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc. due to The device was marketed without a 510k. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device was marketed without a 510k
Recommended Action
Per FDA guidance
On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.
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
CA, GA, IN, VA
Page updated: Jan 10, 2026