FDA Device recall Z-1913-2021
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
- FDA Device
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N by Exact Medical Manufacturing, citing no 510k for the product to be used in a natural or surgical opening to the body.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1913-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-29 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exact Medical Manufacturing |
| Distribution | FL, GA, MT, NY, OH, PR |
Product
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Reason
No 510k for the product to be used in a natural or surgical opening to the body
Identifiers
| code_info | Lot Numbers: 1907E241 1909E199 1908E437 1912E125 2003E828 2005E443 2005E175 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1913-2021%22
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