Medline Recalls 270,311 Convenience Kits with Unapproved Syringe Changes
Summary
FDA Class II recall targets Medline Industries LP for 270,311 convenience kits containing 10mL polycarbonate colored syringes subject to unapproved design changes made outside 510(k) clearance. Affected products include 10 SKU/tray configurations distributed nationwide and to Canada, Panama, and Barbados. The FDA determined cause is component change control, and the firm initiated customer notification on February 27, 2026.
“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.”
What changed
Medline Industries LP initiated a Class II device recall for 270,311 convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The recall stems from unapproved design changes made outside of 510(k) clearance, with FDA's determined cause being component change control. Affected tray configurations include ARTERIOGRAM TRAY, CATH LAB-VEIN PROCEDURES, CENTRAL VENOUS ACCESS PACK-LF, FISTULAGRAM PACK, INVASIVE LINE INSERTION, NON VASCULAR PACK, PICC ABSCESS PACK-LF, PICC LINEPACK (PCLUI)642-LF, and PICC PHC, distributed under lot numbers spanning 2022-2025.
Healthcare providers and facilities that received these kits should identify affected inventory using UDI-DI codes and lot numbers listed in the recall notice. Customers must request over-labels from Medline and apply them to affected kits, then remove and replace the recalled syringe component with product from their supply. Facilities with distributed products in Canada, Panama, and Barbados should coordinate international recall responses accordingly.
What to do next
- 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.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 2 Device Recall MEDLINE CONVENIENCE KITS
- Databases
| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |
| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |
| New Search | ) |
| | Class 2 Device Recall MEDLINE CONVENIENCE KITS | |
| Date Initiated by Firm | February 27, 2026 |
|---|---|
| Date Posted | April 17, 2026 |
| Recall Status | Open , Classified |
| Recall Number | Z-1891-2026 |
| Recall Event ID | 98601 |
| Product Classification | Central venous catheter tray - Product Code OFF |
| 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 |
| Code Information | 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 |
| FEI Number | 1417592 |
| Recalling Firm/
Manufacturer | Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753 |
| For Additional Information Contact | Haley Barclay
800-633-5463 |
| Manufacturer Reason
for Recall | Unapproved design changes to the products outside of the 510(k) clearance. |
| FDA Determined
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. |
| Total Product Life Cycle | TPLC Device Report |
| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |
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