FDA Device recall Z-1921-2021
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
- FDA Device
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 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-1921-2021 |
| 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 - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Reason
No 510k for the product to be used in a natural or surgical opening to the body
Identifiers
| code_info | Lot Numbers: 2008E475 2009E247 2010E217 2012E102 2012E191 |
|---|
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-1921-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.