Z-1919-2021Class II

Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL

Name: Z-1919-2021 Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Creator: Exact Medical Manufacturing, Inc.
Published: 2021-04-29
License: https://open.fda.gov/license/

Exact Medical Manufacturing, Inc. / initiated 2021-04-29 / Terminated

FDA source

Exact Medical Manufacturing, Inc. began a recall of Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL on 2021-04-29. FDA classified it as Class II and gives the reason as "No 510k for the product to be used in a natural or surgical opening to the body". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1919-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-29
Posted: 2021-06-21
Terminated: 2022-05-26
Recalling firm: Exact Medical Manufacturing, Inc.
Product: Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: No 510k for the product to be used in a natural or surgical opening to the body
FDA root cause: No Marketing Application
Action: Exact Medical issued Correction Notification via email on 4/29/21. Letter states: Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not to be used in a natural or surgical opening to the body. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackers/relabelers establishments for further packaging and ethylene oxide sterilization. These are the boundaries and limitations of use for existing Probe/Transducer cover products in any existing stock from Exact Medical Manufacturing, Inc Further instructions will be given at a future date and we encourage you to reach out with any questions or concerns regarding this issue.
Quantity in commerce: 3000 units
Distribution: US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Product codes and lots: Lot Numbers: 2005E091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1919-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1907-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1908-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1909-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1910-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1911-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1912-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1913-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1914-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1915-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1916-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1917-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1918-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1919-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1920-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1921-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1922-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1923-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1924-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21

Product code ITX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)