Exact Medical Manufacturing, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1907-2021)

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" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

Product Classification:

Class II

Date Initiated: April 29, 2021

Date Posted: June 30, 2021

Recall Number: Z-1907-2021

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: 8800 units

Code Information:

Lot Numbers: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated