FDA Device recall Z-1373-2015
Bio-MAC Cannula (Needle) Set
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of Bio-MAC Cannula (Needle) Set by Biologic Therapies, citing devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1373-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-23 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biologic Therapies |
| Distribution | CA, FL, IL, MA, NJ, TX, WA |
Product
Bio-MAC Cannula (Needle) Set
Reason
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Identifiers
| code_info | Catalog Numbers: Part # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1373-2015%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.