Recall Z-1877-2026
Medline Industries, LP · initiated February 27, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246
Codes / lots: DYNJ0373221P UDI-DI 10195327506575 (EA) 40195327506576 (CS) LOTS 24ABR861 DYNJ0516014AI UDI-DI 10198459246234 (EA) 40198459246235 (CS) LOTS 25BME135 25EMI244 DYNJ0545064AA UDI-DI 10195327327385 (EA) 40195327327386 (CS) LOTS 23CMD735 24BMA467 24CME416 24DMG231 24EMI752 24FMD170 24HMD253 24JMC552 24LMA043 25AMJ675 25CMB252 25EMD050 25EMF726 DYNJ0854485X UDI-DI 10195327450366 (EA) 40195327450367 (CS) LOTS 23GMA609 23HMF271 23IMH767 23JMI189 23LMH350 24DMC322 24FMB078 24HMA888 24HMJ182 24LMB120 DYNJ17218R UDI-DI 10195327459642 (EA) 40195327459643 (CS) LOTS 23GDA609 23HDB136 23IDB699 23KDA473 DYNJ28082I UDI-DI 10195327429713 (EA) 40195327429714 (CS) LOTS 23HBC876 23KBE157 24BBC678 24DBN465 24FBQ528 24GBO066 24HBF409 24KBG843 DYNJ30565G UDI-DI 10195327140687 (EA) 40195327140688 (CS) LOTS 22DDB753 22FDB429 22HDB442 22KDA279 22LDB909 23BDB812 23EDA339 23GDA440 23IDA647 23IDB341 23KDB268 24BDA252 24CDB812 24EDC035 24HDC110 24IMA915 24JMI363 24KMG704 24LMF893 DYNJ36752B UDI-DI 10195327226022 (EA) 40195327226023 (CS) LOT 23IMD713 DYNJ37211J UDI-DI 10195327363673 (EA) 40195327363674 (CS) LOTS 24ABL975 24BBM554 24DBA215 24EBF356 24FBR841 24HBF463 24IBV426 24KBC581 24LBM346 DYNJ37389P UDI-DI…
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
FDA-determined cause: Component change control
Action taken
On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
Details
- Recall number
- Z-1877-2026
- Initiated
- February 27, 2026
- Posted by FDA
- April 17, 2026
- Product code
- OES – Cardiac Catheterization Kit
- Quantity
- 270,311 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1876-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1878-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1879-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1880-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1881-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1882-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1883-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1884-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1885-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1886-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1887-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1888-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1889-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1890-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1891-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |
| Z-1892-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | 02/27/2026Open, Classified |