CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
Medline convenience kits labeled as: Lakeland Single Basin Pack-lf recalled
Medline Industries LP - Northfield is recalling Medline convenience kits labeled as: Lakeland Single Basin Pack-lf, distributed nationwide in the US. The recall was initiated on 9 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0634-2025
- FDA event ID
- 95621
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2024
- FDA classified
- 5 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 9 Oct 2024 | Recall initiated by company | |
| 5 Dec 2024 | Classified by FDA | +57 days |
| 11 Dec 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Which lots are affected?
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, UDI/DI 10195327515546 (each) 40195327515547 (case), Lot Numbers: 23KBF131; 10) REF DYNJ50123D, UDI/DI 10195327201999 (each) 40195327201990 (case), Lot Numbers: 22KBI121, 22KBI122, 23CBT112, 23EBB417; 11) REF DYNJ54461F, UDI/DI 10195327155728 (each) 40195327155729 (case), Lot Numbers: 22IMA730, 22LMG820, 23EMB339, 23DMD912, 23HMG790, 23HMC613, 23GMF360, 23IMH847; 12) REF DYNJ54461G, UDI/DI 10195327543570 (each) 40195327543571 (case), Lot Numbers: 23KMA747, 23KBS302, 24ABI360; 13) REF DYNJ54461I, UDI/DI 10195327613730 (each) 40195327613731 (case), Lot Numbers: 24BBG122, 24ABS064, 24DBG019; 14) REF DYNJ54801F, UDI/DI 10195327450861 (each) 40195327450862 (case), Lot Numbers: 23HDC012; 15) REF DYNJ54802I, UDI/DI 10195327450878 (each) 40195327450879 (case), Lot Numbers: 23FDC386, 23IDA377; 16) REF DYNJ59816A, UDI/DI 10195327331573 (each) 40195327331574 (case), Lot Numbers: 23CBV819, 23EBF888; 17) REF DYNJ60529D, UDI/DI 10195327523411 (each) 40195327523412 (case), Lot Numbers: 23JMH503; 18) REF DYNJ60812B, UDI/DI 10195327454630 (each) 40195327454631 (case), Lot Numbers: 23HBL174; 19) REF DYNJ60812C, UDI/DI 10195327521226 (each) 40195327521227 (case), Lot Numbers: 23KBE930, 23JBN323, 23LBN436; 20) REF DYNJ63883C, UDI/DI 10195327221829 (each) 40195327221820 (case), Lot Numbers: 23IDA838, 23GDA969, 23ADA553, 22JDC142, 23KDA710, 24ADB347, 23CDB848, 23EDA013, 24CDA880; 21) REF DYNJ63961D, UDI/DI 10195327428877 (each) 40195327428878 (case), Lot Numbers: 23HDC162, 23GDB814, 23JDA825, 24BDA028, 24DDA624; 22) REF DYNJ65808B, UDI/DI 10195327273552 (each) 40195327273553 (case), Lot Numbers: 23AMI184, 23AMA558; 23) REF DYNJ68217A, UDI/DI 10195327352523 (each) 40195327352524 (case), Lot Numbers: 23CME053, 23FMG407; 24) REF DYNJ82257, UDI/DI 10195327181659 (each) 40195327181650 (case), Lot Numbers: 23IMA316; 25) REF DYNJ82267, UDI/DI 10195327182229 (each) 40195327182220 (case), Lot Numbers: 23GDB214, 23IDC201; 26) REF DYNJ909785, UDI/DI 10195327475819 (each) 40195327475810 (case), Lot Numbers: 23HBU592, 23IBN694; 27) REF DYNJ909923, UDI/DI 10195327504533 (each) 40195327504534 (case), Lot Numbers: 23LMB294, 24BMC919
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
26 other products · FDA event 95621This product is part of a recall event; the main page for the event is Medline convenience kits labeled as: Port Insertion Pack recalled.
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