Recall Register

Device recall: Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC…

Class II FDA enforcement event 94582. 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 94582 has 13 product records. The first FDA enforcement report date is 4 Sep 2024. The record gives the status Ongoing.

FDA enforcement reportThe 13 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.

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

13 product records in the event.

FDA event 94582: product records
Recall numberProductQuantityClassStatusReport date
Z-2623-2024Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2624-2024see RES for description1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2625-2024See RES Description1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2626-2024See RES description1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2627-2024Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number…1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2628-2024See RES description1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2629-2024Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC80451,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2630-2024Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY ,…1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2631-2024Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC80451,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2632-2024Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445; 5) CENTRAL LINE INSERTION KIT W/20CM CATH,…1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2633-2024Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2634-2024Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7)…1,679,067 units in totalClass IIOngoing4 Sep 2024
Z-2635-2024Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NERVE BLOCK ACCESSORY PACK, Pack Number…1,679,067 units in totalClass 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
13Median 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 94582. https://recallregister.com/fda/ii/94582/. 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.
What quantity of product is in FDA event 94582?
The event has 13 product records. The first record gives this quantity: 1,679,067 units in total
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.