Exact Medical Manufacturing, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1914-2021)

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 Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N

Product Classification:

Class II

Date Initiated: April 29, 2021

Date Posted: June 30, 2021

Recall Number: Z-1914-2021

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: 129600 units

Code Information:

Lot Numbers: 1906E228 1907E501 1908E562 1910E027 1910E345 1911E263 1912E541 2003E241 2003E830 2010E342 2011E403

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated