Recall Register

Device recall: Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT…

Class II FDA enforcement event 94581. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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 8 Apr 2024. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 94581 has 27 product records. The first FDA enforcement report date is 4 Sep 2024. The record gives the status Ongoing.

FDA enforcement reportThe 27 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

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

27 product records in the event.

FDA event 94581: product records
Recall numberProductQuantityClassStatusReport date
Z-2739-2024Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327GClass IIOngoing4 Sep 2024
Z-2740-2024Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025HClass IIOngoing4 Sep 2024
Z-2741-2024Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040HClass IIOngoing4 Sep 2024
Z-2742-2024Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095Class IIOngoing4 Sep 2024
Z-2743-2024Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack Number CDS984206R; 7) OPEN HEART PEDS PACK, Pack…Class IIOngoing4 Sep 2024
Z-2744-2024Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920Class IIOngoing4 Sep 2024
Z-2745-2024Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825Class IIOngoing4 Sep 2024
Z-2746-2024Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512AClass IIOngoing4 Sep 2024
Z-2747-2024Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C; 7) ENT PACK, Pack Number…Class IIOngoing4 Sep 2024
Z-2748-2024Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754OClass IIOngoing4 Sep 2024
Z-2749-2024Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271Class IIOngoing4 Sep 2024
Z-2750-2024Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179AH; 6) JSI-MUSCLE&PLASTICS…Class IIOngoing4 Sep 2024
Z-2751-2024Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number ACC010641 ; 6) NEONATAL DRAWER 6 , Pack Number…Class IIOngoing4 Sep 2024
Z-2752-2024Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION…Class IIOngoing4 Sep 2024
Z-2753-2024Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588AClass IIOngoing4 Sep 2024
Z-2754-2024Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670AClass IIOngoing4 Sep 2024
Z-2755-2024Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512Class IIOngoing4 Sep 2024
Z-2756-2024Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512Class IIOngoing4 Sep 2024
Z-2757-2024Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number DYKB1011B; 3) BABY KIT, Pack Number DYKP1021; 4) BABY KIT MED CENTER, Pack Number DYKM2149; 5) BABY KIT MED CENTER, Pack Number DYKM2149A; 6) GIRAFFE BED KIT, Pack Number DYKL1839; 7) GIRAFFE BED KIT,…Class IIOngoing4 Sep 2024
Z-2758-2024Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497Class IIOngoing4 Sep 2024
Z-2759-2024Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909BClass IIOngoing4 Sep 2024
Z-2760-2024Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097Class IIOngoing4 Sep 2024
Z-2761-2024Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCISION TRAY , Pack Number DYNDA3045; 7) CIRCUMCISION…Class IIOngoing4 Sep 2024
Z-2762-2024Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098Class IIOngoing4 Sep 2024
Z-2763-2024Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036BClass IIOngoing4 Sep 2024
Z-2764-2024Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pack Number DYNJ83699A ; 7) BYERS CATARACT,…Class IIOngoing4 Sep 2024
Z-2765-2024Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) ARTHROGRAM TRAY , Pack Number DYNDH1648; 7)…Class IIOngoing4 Sep 2024

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 2024
970
Share of these events in Class II
87%
Product records in this event
27Median 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 94581. https://recallregister.com/fda/ii/94581/. 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
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?
87% of the 970 device events that started in 2024 are in Class II.
How many FDA recalls does MEDLINE INDUSTRIES, LP - Northfield have?
MEDLINE INDUSTRIES, LP - Northfield is the recalling firm in 120 enforcement events on this register. This event is 1 of them.