FDA Device recall Z-0634-2025
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I
- 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) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I 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-0634-2025 |
| 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) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, REF DYNJ0867331G; 6) TOTAL KNEE BASIN B PACK-LF, REF DYNJ0867555L; 7) ST. ANNE'S MINOR BASIN PACK, REF DYNJ24622K; 8) ST. ANNE'S MAJOR BASIN SET UP, REF DYNJ24628M; 9) MAJOR BASIN SET, REF DYNJ41285B; 10) BASIN PACK, REF DYNJ50123D; 11) MAJOR BASIN TRAY, REF DYNJ54461F; 12) MAJOR BASIN TRAY, REF DYNJ54461G; 13) MAJOR BASIN TRAY, REF DYNJ54461I; 14) TR-MINOR KIT-LF, REF DYNJ54801F; 15) TR-MAJOR KIT-LF, REF DYNJ54802I; 16) MAJOR BASIN PACK, REF DYNJ59816A; 17) SINGLE BASIN PACK ST VINCENT, REF DYNJ60529D; 18) BASIN PACK, REF DYNJ60812B; 19) BASIN PACK SH, REF DYNJ60812C; 20) PLASTIC BASIN PACK, REF DYNJ63883C; 21) MINOR PACK, REF DYNJ63961D; 22) OSC BREAST PACK, REF DYNJ65808B; 23) OSC BASIN PACK, REF DYNJ68217A; 24) DELNOR VASCULAR BASIN PACK, REF DYNJ82257; 25) DELNOR BASIN PACK, REF DYNJ82267; 26) STAZ MAJOR BASIN, REF DYNJ909785; 27) LUMBAR, REF DYNJ909923
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 DYNJ0619907I, UDI/DI 10195327239480 (each) 40195327239481 (case), Lot Numbers: 22IMG033; 2) REF DYNJ0619907K,…1) REF DYNJ0619907I, UDI/DI 10195327239480 (each) 40195327239481 (case), Lot Numbers: 22IMG033; 2) REF DYNJ0619907K, UDI/DI 10195327295905 (each) 40195327295906 (case), Lot Numbers: 22LME111; 3) REF DYNJ0619907L, UDI/DI 10195327333119 (each) 40195327333110 (case), Lot Numbers: 23JBH171, 23HBV761, 23FMI052; 4) REF DYNJ06966M, UDI/DI 10195327349059 (each) 40195327349050 (case), Lot Numbers: 23EBR799, 23IBI141, 23KBC445, 23LBJ670; 5) REF DYNJ0867331G, UDI/DI 10195327118433 (each) 40195327118434 (case), Lot Numbers: 22EDA376, 22FDA407; 6) REF DYNJ0867555L, UDI/DI 10195327202613 (each) 40195327202614 (case), Lot Numbers: 23DDB147; 7) REF DYNJ24622K, UDI/DI 10195327109127 (each) 40195327109128 (case), Lot Numbers: 23ABN514, 22EBS282, 22EBE400, 23CBV810, 23CBH097, 23EBT659; 8) REF DYNJ24628M, UDI/DI 10195327109134 (each) 40195327109135 (case), Lot Numbers: 22FLA375, 22DLA993, 22ILA590, 23GLA918, 23FLA366, 23DLA800, 23BLA536, 22JLA323, 23CLB087; 9) REF DYNJ41285B, |
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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-0634-2025%22
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