Food, drugs, devices › Medline Industries, LP

Device recall: Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B

FDA enforcement event 98284 · Class II · initiated 24 Dec 2025 · status Ongoing

DeviceVoluntary: Firm initiated11 product recordsNorthfield, IL

Medline Industries, LP (Northfield, IL) initiated this device recall on 24 Dec 2025; FDA lists 11 product records under event 98284, classified Class II.

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 items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators."

Distribution

"US Nationwide distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1326-2026	Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B	120 kits	Class II	Ongoing	18 Feb 2026
Z-1327-2026	Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109	1350 kits	Class II	Ongoing	18 Feb 2026
Z-1328-2026	Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108	450 kits	Class II	Ongoing	18 Feb 2026
Z-1329-2026	Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC…	7570 kits	Class II	Ongoing	18 Feb 2026
Z-1330-2026	1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU…	21854 units	Class II	Ongoing	18 Feb 2026
Z-1331-2026	Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.	7380 kits	Class II	Ongoing	18 Feb 2026
Z-1332-2026	Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A	2448 kits	Class II	Ongoing	18 Feb 2026
Z-1333-2026	Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088	4300 kits	Class II	Ongoing	18 Feb 2026
Z-1334-2026	Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL…	8445 kits	Class II	Ongoing	18 Feb 2026
Z-1335-2026	Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A	216 kits	Class II	Ongoing	18 Feb 2026
Z-1336-2026	Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B	168 units	Class II	Ongoing	18 Feb 2026

Context

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

11product 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 items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators."

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.