FDA Device recall Z-1721-2016
American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges by American Surgical, citing product packaging defective compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1721-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | American Surgical |
| Distribution | US |
Product
American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Reason
Product packaging defective compromising sterility
Identifiers
| code_info | Lot Number:/ 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1721-2016%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.