Food, drugs, devices › Medline Industries, LP

Device recall: MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M

FDA enforcement event 97846 · Class II · initiated 30 Sep 2025 · status Ongoing

DeviceVoluntary: Firm initiated20 product recordsNorthfield, IL

FDA enforcement event 97846 is a device recall by Medline Industries, LP of Northfield, IL, initiated 30 Sep 2025 and classified Class II, with 20 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Medline Industries, LP has 66 enforcement events on this register, with a median of 5 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Medline Industries, LP, Northfield, IL.

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…"

Distribution

"US Nationwide distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0511-2026	MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M	48 kits	Class II	Ongoing	26 Nov 2025
Z-0512-2026	MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A	12 kits	Class II	Ongoing	26 Nov 2025
Z-0513-2026	MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF…	5133 kits	Class II	Ongoing	26 Nov 2025
Z-0514-2026	MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.	142 kits	Class II	Ongoing	26 Nov 2025
Z-0515-2026	MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.	301 units	Class II	Ongoing	26 Nov 2025
Z-0516-2026	MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF,…	3078 kits	Class II	Ongoing	26 Nov 2025
Z-0517-2026	MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF CDS860194I; 7) BASIC LAPAROSCOPY CDS, REF…	28679 kits	Class II	Ongoing	26 Nov 2025
Z-0518-2026	MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597	12 kits	Class II	Ongoing	26 Nov 2025
Z-0519-2026	MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #87-RF, REF DYNJ27319V; 7) BREAST AUGMENTATION PACK,…	4214 kits	Class II	Ongoing	26 Nov 2025
Z-0520-2026	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.	1921 kits	Class II	Ongoing	26 Nov 2025
Z-0521-2026	MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJOR ABDOMINAL CDS, REF CDS983908Q; 8) LOWER EXTREMITY…	20941 kits	Class II	Ongoing	26 Nov 2025
Z-0522-2026	MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.	1315 kits	Class II	Ongoing	26 Nov 2025
Z-0523-2026	MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.	424 kits	Class II	Ongoing	26 Nov 2025
Z-0524-2026	MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 7) LAP-GYN PACK, REF DYNJ44876M; 8) ROBOT PACK,…	2844 kits	Class II	Ongoing	26 Nov 2025
Z-0525-2026	MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O	120 kits	Class II	Ongoing	26 Nov 2025
Z-0526-2026	MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECTION PACK-LF, REF DYNJ0551409P; 8) C-SECTION PACK-LF,…	11032 kits	Class II	Ongoing	26 Nov 2025
Z-0527-2026	MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 7) URO GYN,…	570 kits	Class II	Ongoing	26 Nov 2025
Z-0528-2026	MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F	18 units	Class II	Ongoing	26 Nov 2025
Z-0529-2026	MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.	345 kits	Class II	Ongoing	26 Nov 2025
Z-0530-2026	MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 8) TOTAL HIP…	40151 kits	Class II	Ongoing	26 Nov 2025

Context

85%of 2025 device events are Class II945 events that year

20product records in this eventfirm median: 5

66events on this register for the firm

Other enforcement events for Medline Industries, LP

Initiated	Product (first record)	Type	Class	Records
11 Aug 2026	Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A	Device	Class I	7
31 Jul 2026	Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A	Device	Class II	4
23 Jul 2026	Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N	Device	Class II	1
20 Jul 2026	Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A	Device	Class II	13
13 Jul 2026	Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Numbe	Device	Class II	3
10 Jul 2026	Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330	Device	Class II	1
10 Jul 2026	Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D	Device	Class II	11
8 Jul 2026	Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit S	Device	Class II	4
30 Jun 2026	Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN	Device	Class II	4
12 Jun 2026	Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Mo	Device	Class II	16

All 66 events for Medline Industries, LP

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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…"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.