Drug & Device Safety Atlas
Class II FDA device recall · Z-0634-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution.

Recall record

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product type
Devices
Recall number
Z-0634-2025
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin
Northfield, IL
Recall initiated
2024-10-09

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0634-2025 · Source: openFDA enforcement.