Device recall: Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG…

Class II FDA enforcement event 98599. Recall start date: 25 Feb 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Class II, in the words of FDA

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

Medline Industries, LP started this device recall on 25 Feb 2026. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 98599 has 22 product records. The first FDA enforcement report date is 29 Apr 2026. The record gives the status Ongoing.

FDA enforcement report The 22 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution.

Recalling firm

Medline Industries, LP, Northfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

22 product records in the event.

FDA event 98599: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1829-2026	Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model…	74,085 units	Class II	Ongoing	29 Apr 2026
Z-1830-2026	Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;	24,170 units	Class II	Ongoing	29 Apr 2026
Z-1831-2026	Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6)…	38,230 units	Class II	Ongoing	29 Apr 2026
Z-1832-2026	Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D	15 units	Class II	Ongoing	29 Apr 2026
Z-1833-2026	Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A	58836 units	Class II	Ongoing	29 Apr 2026
Z-1834-2026	Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number:…	3183 units	Class II	Ongoing	29 Apr 2026
Z-1835-2026	Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number:…	160883 units	Class II	Ongoing	29 Apr 2026
Z-1836-2026	Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6)…	19189 units	Class II	Ongoing	29 Apr 2026
Z-1837-2026	Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A	20 units	Class II	Ongoing	29 Apr 2026
Z-1838-2026	Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A	39 units	Class II	Ongoing	29 Apr 2026
Z-1839-2026	Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C	513 units	Class II	Ongoing	29 Apr 2026
Z-1840-2026	Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y	75 units	Class II	Ongoing	29 Apr 2026
Z-1841-2026	Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D	36 units	Class II	Ongoing	29 Apr 2026
Z-1842-2026	Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT…	38014 units	Class II	Ongoing	29 Apr 2026
Z-1843-2026	Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C	198210 units	Class II	Ongoing	29 Apr 2026
Z-1844-2026	Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817	9645 units	Class II	Ongoing	29 Apr 2026
Z-1845-2026	Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D	1720 units	Class II	Ongoing	29 Apr 2026
Z-1846-2026	Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F	6 units	Class II	Ongoing	29 Apr 2026
Z-1847-2026	Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B	89 units	Class II	Ongoing	29 Apr 2026
Z-1848-2026	Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B	12 units	Class II	Ongoing	29 Apr 2026
Z-1849-2026	Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number:…	2609 units	Class II	Ongoing	29 Apr 2026
Z-1850-2026	Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440	27 units	Class II	Ongoing	29 Apr 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class II: 87%
Product records in this event: 22Median of the firm: 5
Events of the firm on the register: 66

Other events of the firm

Other FDA enforcement events of 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

Medline Industries, LP: all 66 events

Official channels

FDA enforcement report Z-1829-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 98599. https://recallregister.com/fda/ii/98599/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution.
What quantity of product is in FDA event 98599?: The event has 22 product records. The first record gives this quantity: 74,085 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 572 device events that started in 2026 are in Class II.