Recall Register

Device recall: Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;

Class II FDA enforcement event 96510. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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 - Northfield started this device recall on 3 Mar 2025. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 96510 has 34 product records. The first FDA enforcement report date is 23 Apr 2025. The record gives the status Ongoing.

FDA enforcement reportThe 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 . openFDA export of .

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield, 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 96510: product records
Recall numberProductQuantityClassStatusReport date
Z-1586-2025Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;36 unitsClass IIOngoing23 Apr 2025
Z-1587-2025Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A60 unitsClass IIOngoing23 Apr 2025
Z-1588-2025Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;40 unitsClass IIOngoing23 Apr 2025
Z-1589-2025Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;8 unitsClass IIOngoing23 Apr 2025
Z-1590-2025Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C2,118 unitsClass IIOngoing23 Apr 2025
Z-1591-2025Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH PACK, Model Number: DYNJ51338C; 6) BRISTOL…4022 unitsClass IIOngoing23 Apr 2025
Z-1592-2025Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK,…3205 unitsClass IIOngoing23 Apr 2025
Z-1593-2025Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ82437A; 5) C LINE INSERTION CDS, Model Number:…3808 unitsClass IIOngoing23 Apr 2025
Z-1594-2025Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 5) PROCEDURE MINEURE BJC-LF, Model Number:…1126 unitsClass IIOngoing23 Apr 2025
Z-1595-2025Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841C; 6) NYGH-MINOR DENTAL-PLASTIC-LF, Model…573 unitsClass IIOngoing23 Apr 2025
Z-1596-2025Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F56 unitsClass IIOngoing23 Apr 2025
Z-1597-2025Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL…9216 unitsClass IIOngoing23 Apr 2025
Z-1598-2025Refer to RES14760 unitsClass IIOngoing23 Apr 2025
Z-1599-2025Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S530 unitsClass IIOngoing23 Apr 2025
Z-1600-2025Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Model Number: DYNJ66056; 6) MUSCLE PLASTIC PACK,…4094 unitsClass IIOngoing23 Apr 2025
Z-1601-2025Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B116 unitsClass IIOngoing23 Apr 2025
Z-1602-2025Refer to RES28127 unitsClass IIOngoing23 Apr 2025
Z-1603-2025Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS1259045 unitsClass IIOngoing23 Apr 2025
Z-1604-2025Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ8842284 kitsClass IIOngoing23 Apr 2025
Z-1605-2025Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;6 unitsClass IIOngoing23 Apr 2025
Z-1606-2025Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS627048 unitsClass IIOngoing23 Apr 2025
Z-1607-2025Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339Class IIOngoing23 Apr 2025
Z-1608-2025Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD023990 unitsClass IIOngoing23 Apr 2025
Z-1609-2025Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C40 unitsClass IIOngoing23 Apr 2025
Z-1610-2025Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model Number: DYNJ53032C354 unitsClass IIOngoing23 Apr 2025
Z-1611-2025Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5) PACK VAGINAL DELIVERY, Model Number: HM190A;…21935 unitsClass IIOngoing23 Apr 2025
Z-1612-2025Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B48 unitsClass IIOngoing23 Apr 2025
Z-1613-2025Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE LITHOMIE MINEURE-LF, Model Number: DYNJ47552C;…706 unitsClass IIOngoing23 Apr 2025
Z-1614-2025Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model…1098 unitsClass IIOngoing23 Apr 2025
Z-1615-2025Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PERI GYN, Model Number: DYNJ67708A; 6)…671 unitsClass IIOngoing23 Apr 2025
Z-1616-2025Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C…2,531 unitsClass IIOngoing23 Apr 2025
Z-1617-2025Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number: DYNJ85284; 6) PHACO PACK, Model Number:…3909 unitsClass IIOngoing23 Apr 2025
Z-1618-2025Refer to RES11889 unitsClass IIOngoing23 Apr 2025
Z-1619-2025Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B222 unitsClass IIOngoing23 Apr 2025

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 2025
945
Share of these events in Class II
85%
Product records in this event
34Median of the firm: 2
Events of the firm on the register
120

Other events of the firm

Other FDA enforcement events of MEDLINE INDUSTRIES, LP - Northfield
InitiatedProduct (first record)TypeClassRecords
25 Jul 2025Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRDeviceClass I2
23 Jul 2025Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DeviceClass II1
14 Jul 2025Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH,DeviceClass I1
8 Jul 2025The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utiliDeviceClass II1
7 Jul 2025Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, ManufDrugClass II6
16 Jun 2025SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301DeviceClass II1
12 Jun 2025Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564DeviceClass II4
23 May 2025Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER DeviceClass II3
15 May 2025Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250DeviceClass II1
22 Apr 2025Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS98DeviceClass I3

MEDLINE INDUSTRIES, LP - Northfield: all 120 events

Official channels

Cite this page

Recall Register. FDA enforcement event 96510. https://recallregister.com/fda/ii/96510/. Source: openFDA enforcement reports. Data through .

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: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
What quantity of product is in FDA event 96510?
The event has 34 product records. The first record gives this quantity: 36 units
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?
85% of the 945 device events that started in 2025 are in Class II.