Hays Ultrasound kit Item ID: H1000SE — Class II medical device recall Z-1918-2021
Terminated recall by Exact Medical Manufacturing, Inc., reported 2021-06-30, distributed in FL, GA, MT, NY, OH, PR. No 510k for the product to be used in a natural or surgical opening to the body
| Recall number | Z-1918-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exact Medical Manufacturing, Inc., Lancaster, NY, United States |
| Recall initiated | 2021-04-29 |
| Classified | 2021-06-21 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2022-05-26 |
| Distributed | FL, GA, MT, NY, OH, PR |
| Quantity | 10,020 units |
| Lot numbers | 2005E090, 2006E495 |
| Model numbers | H1000SE |
Product
Hays Ultrasound kit Item ID: H1000SE
Reason for recall
No 510k for the product to be used in a natural or surgical opening to the body
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1918-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.