Exact Medical Manufacturing, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1918-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Hays Ultrasound kit Item ID: H1000SE

Product Classification:

Class II

Date Initiated: April 29, 2021

Date Posted: June 30, 2021

Recall Number: Z-1918-2021

Event ID: 87958

Reason for Recall:

No 510k for the product to be used in a natural or surgical opening to the body

Status: Terminated

Product Quantity: 10020 units

Code Information:

Lot Numbers: 2005E090 2006E495

Distribution Pattern:

US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated