Z-1891-2026Class II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-27 / Open, Classified / root cause: design
Medline Industries, LP began a recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES... on . FDA classified it as Class II and gives the reason as "Unapproved design changes to the products outside of the 510(k) clearance". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1891-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- 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 PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C
- Product code
- OFF Central Venous Catheter Tray
- Reason for recall
- Unapproved design changes to the products outside of the 510(k) clearance.
- Root cause tag
- design
- FDA root cause
- Component change control
- Action
- 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.
- Quantity in commerce
- 270,311 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
- Product codes and lots
- 00-402001T UDI-DI 10193489939682 (EA) 40193489939683 (CS) LOTS 23EBT729 23GBR995 23GBS336 00-402001U UDI-DI 10195327517380 (EA) 40195327517381 (CS) LOTS 23JBU819 23LBG449 24ABS585 24CBF190 24DBA960 24EBB048 24FBN231 24HBA892 24IBD316 24IBS824 DYNJ60329A UDI-DI 10193489972221 (EA) 40193489972222 (CS) LOT 24ABP714 CVI5070 UDI-DI 10195327526061 (EA) 40195327526062 (CS) LOT 24FBF359 DYNJ66259 UDI-DI 10193489325485 (EA) 40193489325486 (CS) LOT 22FMB867 DYNJ44123C UDI-DI 10195327599140 (EA) 40195327599141 (CS) LOTS 24ABQ097 24DMH637 24FMG692 24GMA523 24HME792 24JMA878 24JMI393 DYNJ68037B UDI-DI 10195327476458 (EA) 40195327476459 (CS) LOT 24HBK116 DYNJ68037C UDI-DI 10198459239328 (EA) 40198459239329 (CS) LOT 25BBO522 25DBR880 DYNJ0774005G UDI-DI 10193489271485 (EA) 40193489271486 (CS) LOTS 23DMC237 23EMC431 23FMG987 23HBL979 23JBG840 23KBJ401 23LBR858 24CBB784 24EBA777 DYNJ47717B UDI-DI 10195327355302 (EA) 40195327355303 (CS) LOTS 23GMB288 23HMA341 23HMH322 DYNJ37484C UDI-DI 10195327397340 (EA) 40195327397341 (CS) LOTS 24EDB695 24HDC050 24IMH716 24JMH721 24KMG262 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** 00-402001T Lots 21GBL509 21JBN647 21JBZ697 22BBX248 22DBL467 22DBS962 22GBC939 22HBO291 22HBO322 22IBN444 22IBO023 22KBT315 23BBA151 23CBI235 23DBM140; DYNJ0774005G Lots 21AMC932 21CMB295 21EMA842 21EMA842Z 21GME190 21IMF074 21JMA971 22AMB224 22CMF849 22CMG025 22DMF774 22HMD145 22HMH991 22JMF788 23AMH034 23CMA447; DYNJ37484C Lots 23EDA007 23GDA068 23HDC049 23JDA140 23LDA212 24BDA222 24DDA235 25AMA456 25AMH943; DYNJ44123C Lots 25BMC026; DYNJ47717B Lots 23DME176; DYNJ68037B Lots 23JBM013 23LBR847 24CBM608 24DBQ050 24HBT816 25ABA997
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1876-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1877-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1878-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1879-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1880-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1881-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1882-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1883-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1884-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1885-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1886-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1887-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1888-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1889-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1890-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1891-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1892-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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