Exact Medical Manufacturing, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1911-2021)

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:

Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N

Product Classification:

Class II

Date Initiated: April 29, 2021

Date Posted: June 30, 2021

Recall Number: Z-1911-2021

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: 12650 units

Code Information:

Lot Numbers: 2003E829 2003E242 2004E033 2005E165 2005E164 2005E176 2005E440 2011E107 2011E250 2101E070 2012E509

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated