FDA Device recall Z-0104-2027
MAJOR PACK
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of MAJOR PACK by Avid Medical, citing product may be potentially contaminated with a lubricant used during the manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0104-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
Reason
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Identifiers
| code_info | Model/Item Number (Kit): NIHB0018-11; UDI-DI: 10809160403747; Kit Lot Numbers: 1667763; Recalled Supplier Component (i…Model/Item Number (Kit): NIHB0018-11; UDI-DI: 10809160403747; Kit Lot Numbers: 1667763; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKT3375; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Avid Medical
- GYN LAPAROSCOPY/LAPAROTOMY
FDA Device · Class II · 2026-10-14 · Avid Medical - LAPAROSCOPIC PROSTATECTOMY
FDA Device · Class II · 2026-10-14 · Avid Medical - GYN LAPAROSCOPY PACK
FDA Device · Class II · 2026-10-14 · Avid Medical - ABD HYSTERECTOMY
FDA Device · Class II · 2026-10-14 · Avid Medical - CRANIOTOMY PACK
FDA Device · Class II · 2026-10-14 · Avid Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0104-2027%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.