FDA Device recall Z-2277-2019
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 by Suntech Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2277-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-03 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Suntech Medical |
| Distribution | n/a |
Product
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Reason
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.
Identifiers
| code_info | Catalog # 98-0400-98 Lot Number: A4H201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2019%22
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