SunTech Medical Disposable — Class II medical device recall Z-2277-2019
Terminated recall by Suntech Medical, Inc., reported 2019-08-21. Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was plac
| Recall number | Z-2277-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Suntech Medical, Inc., Morrisville, NC, United States |
| Recall initiated | 2019-06-03 |
| Classified | 2019-08-14 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2020-12-16 |
| Countries outside the US | PK |
| Reason classes | labeling |
| Lot numbers | A4H201 |
| Model numbers | 98-0400-98 |
Product
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Reason for recall
Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.
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-2277-2019. 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.