FDA Device recall Z-0628-2025
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I by Medline Industries Northfield, citing medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0628-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Reason
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Identifiers
| code_info | 1) REF DYNJ52404I, UDI/DI 10195327339159 (each) 40195327339150 (case), Lot Numbers: 23HDB384, 23IDC338; 2) REF DYNJ…1) REF DYNJ52404I, UDI/DI 10195327339159 (each) 40195327339150 (case), Lot Numbers: 23HDB384, 23IDC338; 2) REF DYNJ59073B, UDI/DI 10195327200398 (each) 40195327200399 (case), Lot Numbers: 23CBG401, 22JBI913, 23GBU324, 23EBL522, 23BBA464, 23CBU743, 23IBS781; 3) REF DYNJ80226A, UDI/DI 10195327195021 (each) 40195327195022 (case), Lot Numbers: 22GBV225, 22FBV173, 22FBV174; 4) REF DYNJ83140, UDI/DI 10195327232955 (each) 40195327232956 (case), Lot Numbers: 22JBN386 |
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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-0628-2025%22
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