Z-1917-2021 Class II Terminated
FDA device recall Z-1917-2021 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: 51300 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
- 51300 units
Product description
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
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: 1906E310 1908E208 1908E561 1910E032 1910E350 1911E262 1912E540 2003E308 2002E135 2003E324 2004E513 2009E129 2009E408 2101E069 2011E404
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1917-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026