MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3
Summary
The FDA issued a Class II for MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ3769 by Medline Industries, LP. Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instru.
Details
Source
Device Recall
External ID
Z-0520-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
Lot/Code Info: 1) REF DYNJ37698L: UDI/DI 10195327435523 (each) 40195327435524, (case), Lot Numbers: 23KMG076, 24AMA944, 24FMA911; 2) REF DYNJ50123D: UDI/DI 10195327201999 (each) 40195327201990, (case), Lot Numbers: 23FBP789, 24ABG308, 24BBQ467, 24DBP157; 3) REF DYNJ59816A: UDI/DI 10195327331573 (each) 40195327331574, (case), Lot Numbers: 23GBR142, 23IBJ642, 23LBD170, 23LBM241; 4) REF DYNJ68217A: UDI/DI 10195327352523 (each) 40195327352524, (case), Lot Numbers: 23EMB405, 23IMH248.
Quantity Affected: 1921 kits
Reason for Recall
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-30
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0520-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29