Medline Convenience Kits Recall - 270,311 Units Due to Unapproved Design Changes
FDA Device Recalls (Class II)
Summary
FDA classified a Class II recall initiated by Medline Industries, LP for certain convenience kit SKUs containing 10mL Polycarbonate Colored Syringes. The recall affects 270,311 total units distributed US Nationwide and to Canada, Panama, and Barbados. The firm determined the root cause to be unapproved design changes made outside of 510(k) clearance, with FDA citing component change control as the causal factor.
“Unapproved design changes to the products outside of the 510(k) clearance.”
What changed
Medline Industries initiated a Class II device recall for select convenience kit SKUs after determining that unapproved design changes were made to the 10mL Polycarbonate Colored Syringes included in those kits, outside the required 510(k) clearance process. FDA classified this as a recall and identified component change control as the root cause. The affected kits include angiography, angioplasty, catheter lab, and related surgical packs across multiple product codes (DYNJ series) with numerous lot numbers.
Healthcare providers and facilities that received these kits should identify any inventory containing the listed SKUs and lot numbers, contact Medline at 800-633-5463 to request over-labeling instructions, and remove and replace the recalled syringes per the firm's instructions. Facilities performing angiography, catheterization, or related interventional procedures should audit their supply chains for these product codes to confirm whether affected product is in stock.
What to do next
- Contact recalling firm at 800-633-5463 for information
- Request over-labels to place on affected kits instructing removal of recalled component and replacement with product from 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-1876-2026 |
| Recall Event ID | 98601 |
| Product Classification | Angiography/angioplasty kit - Product Code OEQ |
| Product | 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 PACK DYNJ39057C
FEMORAL ANGIOGRAPY SET UP DYNJ61015B
RAD-ANGIO PACK DYNJ47710C
SURGERY ANGIO PACK-LF PHS677784013A |
| Code Information | DYNJ51126
UDI-DI 10889942122820 (EA)
40889942122821 (CS)
LOT 20ADA585
DYNJ32555C
UDI-DI 10193489859485 (EA) 40193489859486 (CS)
LOTS 21HMF699
21IMF813
21JMA855
21KMD605
22DMB423
22FMD574
22HMB608
22LMA169
23BMA114
23EMB817
23EMG153
23KMB692
23KMH359
23LMH085
24AMC563
24CMD587
24DMD256
24DMG305
24FMD717
24IMI650
24JMC830
DYNJ66631
UDI-DI 10193489368321 (EA) 40193489368322 (CS)
LOTS 22BBB494
22BBB497
DYNJ46153B
UDI-DI 10193489853643 (EA) 40193489853644 (CS)
LOTS 23EBM225
23FBC884
23HBP278
23IBV999
23KBC319
23LBK125
24CBF100
24DBE952
24FBP262
24GBN960
24HBO921
24IBO007
24IBU941
24JBK669
24LBK644
DYNJ26855F
UDI-DI 10888277012042 (EA) 40888277012043 (CS)
LOTS 20CBI049
20EBB600
20FBK900
20GBD331
20GBL795
20IBC788
20JBM786
20KBF148
21BBK244
21EBR327
21HBB849
21IBQ809
21OBA396
DYNJ24530I
UDI- DI 10193489674910 (EA) 40193489674911 (CS)
LOT 24ABU775
DYNJ0220880V
UDI-DI 10889942054688 (EA) 40889942054689 (CS)
LOTS 23HLA505
23HLB257
23JLA021
23JLA059
23KLA121
23KLA231
23KLA582
23LLA817
24ELA405
24ELA796
24HLA596
25AMI609
25BMH660
25CMA797
25DMF893
DYNJ30077D
UDI-DI 10889942138630 (EA) 40889942138631 (CS)
LOTS 23FBQ479
23LBL707
24CBC495
24EBQ346
24GBK895
24HBD023
24HBP290
24JBJ112
DYNJ0545064X
UDI-DI 10193489747621 (EA) 40193489747622 (CS)
LOTS 20BBL115
20CBA649
20DBB933
20DBP595
20HBW939
20KBI815
21ABK039
21ABK542
DYNJ39057C
UDI-DI 10193489765519 (EA) 40193489765510 (CS)
LOT 24BBD166
DYNJ61015B
UDI-DI 10193489368888 (EA) 40193489368889 (CS)
LOTS 23CMG023
23FBN151
DYNJ47710C
UDI-DI 10889942214495 (EA) 40889942214496 (CS)
LOTS 23FBF109
23GBB677
23JBP270
23LBO688
24DBD356
24FBP326
24IBC340
24KBJ788
PHS677784013A
UDI-DI 10193489604337 (EA) 40193489604338 (CS)
LOTS 20BBR301
20IMA683
21BMC467
21CMC052
21FMD140
21IMF229
22AMA959
22AME458
23GMA491
23GMD585 |
| 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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