FDA Device recall Z-0159-2025
Medline DENTAL PACK, REF DYNJ64086B
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Medline DENTAL PACK, REF DYNJ64086B by Medline Industries Northfield, citing it has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0159-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-04 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Reason
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Identifiers
| code_info | UDI/DI 40195327120420 (each), 10195327120429 (case), Lot Numbers: 24ABF266 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0159-2025%22
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