Z-1919-2021 Class II Terminated
FDA device recall Z-1919-2021 was initiated by Exact Medical Manufacturing, Inc. on Apr 29, 2021 and is designated Class II. Reason for recall: No 510k for the product to be used in a natural or surgical opening to the body The recall status is terminated (terminated May 26, 2022). Affected quantity: 3000 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 30, 2021
- Initiation Date
- Apr 29, 2021
- Termination Date
- May 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3000 units
Product description
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Reason for recall
No 510k for the product to be used in a natural or surgical opening to the body
Distribution pattern
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Code information
Lot Numbers: 2005E091
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1919-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026