Serrated Blade Applicator Kit — Class II medical device recall Z-1975-2023
Ongoing recall by Helena Laboratories, Corp., reported 2023-06-28, distributed in AR, CA, FL, MI, NE, NY, PA, TX. Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample).
| Recall number | Z-1975-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2023-05-02 |
| Classified | 2023-06-16 |
| Reported by FDA | 2023-06-28 |
| Distributed | AR, CA, FL, MI, NE, NY, PA, TX |
| Countries outside the US | TH |
| Quantity | 32 units |
| Lot numbers | 3-22 |
| Model numbers | 552687 |
Product
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Reason for recall
Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
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-1975-2023. 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.