Device recall: Medline EBSI Kit EBSI1534

Class II FDA enforcement event 98951. Recall start date: 27 Apr 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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 27 Apr 2026. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 98951 has 34 product records. The first FDA enforcement report date is 24 Jun 2026. The record gives the status Ongoing.

FDA enforcement report The 34 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. OUS distribution pending.

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

34 product records in the event.

FDA event 98951: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2414-2026	Medline EBSI Kit EBSI1534	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2415-2026	Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2416-2026	BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2417-2026	MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2418-2026	Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2419-2026	Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889C	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2420-2026	Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2421-2026	Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2422-2026	Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-LF DYNJ60095B FREE FLAP CUSTOM PACK B DYNJ82736B FREE NIPPLE GRAFT…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2423-2026	Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ909926C JVL - MODULE PLASTIC PK DYNJ84081B KIT MAJOR PLASTICS MOSES DYNJ905362C MEM MAXILLOFACIAL PACK-LF DYNJ0660040R MINOR BREAST PACK DYNJ89023A PLASTIC MAJOR SURGERY DYNJ902510M…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2424-2026	Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINCI PACK SURGICOUNT DYNJ45544F EPCH BASIC PACK DYNJ83094C GENERAL PACK DYNJ39682B DYNJ84882 GENERAL RFD DYNJ906336F GENERAL SURGERY PACK…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2425-2026	Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2426-2026	Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2427-2026	Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2428-2026	Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2429-2026	Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2430-2026	Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2431-2026	Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2432-2026	Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2433-2026	Medline convenience kits: WT LAVH PACK DYNJ46609F	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2434-2026	Medline convenience kits: DAVINCI MAIN DYNJ908031D	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2435-2026	Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2436-2026	Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2437-2026	Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINTENANCE KIT DT17570 DIALYSIS DRESSING CHANGE KIT DT21370B DRESSING CHANGE TRAY - GOLD DT21115B PORT DRESSING CHANGE KIT DYNDC2815A	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2438-2026	Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2439-2026	Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2440-2026	Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2441-2026	Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2442-2026	Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2443-2026	Medline convenience kits: PORT A CATH DYNJ906818A	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2444-2026	Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK…	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2445-2026	Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2446-2026	Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P	49,654 kits total	Class II	Ongoing	24 Jun 2026
Z-2447-2026	Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L	49,654 kits total	Class II	Ongoing	24 Jun 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: 34Median 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-2414-2026The 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 98951. https://recallregister.com/fda/ii/98951/. 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. OUS distribution pending.
What quantity of product is in FDA event 98951?: The event has 34 product records. The first record gives this quantity: 49,654 kits total
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.