Food, drugs, devices › Medline Industries, LP
Device recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK
FDA enforcement event 98601 is a device recall by Medline Industries, LP of Northfield, IL, initiated 27 Feb 2026 and classified Class II, with 17 product records.
FDA defines Class II as 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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medline Industries, LP has 66 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medline Industries, LP, Northfield, IL.
Reason for recall
"Unapproved design changes to the products outside of the 510(k) clearance."
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1876-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB… | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1877-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118… | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1878-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP… | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1879-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1880-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262 | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1881-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599 | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1882-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639 | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1883-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109… | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1884-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY… | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1885-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1886-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1887-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK DYNJ41250B | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1888-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1889-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1890-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T ARTERIOGRAM NEURO PACK-LF DYNJ0842499L… | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1891-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS… | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
| Z-1892-2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G | 270,311 total | Class II | Ongoing | 29 Apr 2026 |
Context
Other enforcement events for Medline Industries, LP
All 66 events for Medline Industries, LP
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Unapproved design changes to the products outside of the 510(k) clearance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.