Class 2 Recall Medline Convenience Kits 10mL Polycarbonate Syringes
Summary
FDA classified a Class 2 recall for Medline Industries LP convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The recall (Z-1878-2026, Event ID 98601) was initiated on February 27, 2026 after the firm determined that unapproved design changes were made to the products outside of 510(k) clearance. The FDA-determined cause is component change control. Affected customers were instructed to request over-labels to place on recalled kits instructing them to remove and replace the recalled component.
“On February 27, 2026, the firm began notifying customers via email and first-class mail.”
What changed
FDA classified a Class 2 recall for Medline Industries LP convenience kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of 510(k) clearance. The firm initiated the recall on February 27, 2026. The recall affects 270,311 total units distributed nationwide in the US and to Canada, Panama, and Barbados.
Healthcare providers and distributors should immediately verify their inventory against the 38 affected kit SKUs and associated lot numbers listed in the recall notice. Customers should contact Haley Barclay at 800-633-5463 to request over-labels and follow the instructions to remove and replace the recalled syringe component.
What to do next
- Contact Haley Barclay at 800-633-5463 for information
- Request over-labels to place on affected kits containing recalled syringes
- Remove the recalled component and replace 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-1878-2026 |
| Recall Event ID | 98601 |
| Product Classification | Cardiovascular procedure kit - Product Code OEZ |
| Product | 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 PACK DYNJ47782G
EPS ACCESSORY PACK DYNJT2201S
H CLINIC VASCULAR PK DYNJ33415A
HEART FAILURE PACK DYNJ64877B
HYBRID PACK DYNJ65925D
INTERVENTIONAL RAD PACK DYNJ44100M
INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG
MV-PACEMAKER PACK-LF DYNJ41556F
NEURO RADIOLOGY RICHMOND DYNJ68365D
OR HYBRID-M DYNJ907758D, DYNJ907758F
PACEMAKER DYNJ907960C
PACEMAKER PACK DYNJ42557B
DYNJ61411
DYNJ61411A
DYNJ61411B
DYNJ80160
PACER PACK DYNJ40952B
PERIPHERAL ARTERIOGRAM RAD DYNJ61383B
RADIOLOGY PACK DYNJ54762D
TAVR PACK DYNJ55338B
DYNJ69246A
VASCULAR ACCESS TRAY DYNJ52606F
VASCULAR TRAY DYNJ49802C
VEIN PACK DYNJ57512
DYNJ58063
DYNJ84953 |
| Code Information | DYNJ69246B
UDI-DI
10198459335266 (EA)
40198459335267 (CS)
LOT 25EBM356
DYNJ905291D
UDI-DI 10195327393090 (EA) 40195327393091 (CS)
LOTS 24JBO127
24LBJ199
DYNJ86769
UDI-DI 10195327674168 (EA) 40195327674169 (CS)
LOT 24EMF716
DYNJ26783D
UDI-DI 10193489616750 (EA) 40193489616751 (CS)
LOTS 23DBJ248
23EBK921
23FBS130
23HBB516
23IBS065
23JBP123
23LBP196
24ABR004
24ABR121
24BBG855
24GBV377
24JBI914
24KBD153
24LBB665
DYNJ35615G
UDI-DI 10195327099404 (EA) 40195327099405 (CS)
LOT 23EBR748
DYNJ0842516G
UDI-DI 10195327286392 (EA) 40195327286393 (CS)
LOTS 24CDB991
24GDB891
24IDA796
24KDB683
DYNJ61926
UDI-DI 10193489610406 (EA) 40193489610407 (CS)
LOTS 23CBK311
23DBM226
23FBP893
23GBN159
23HBC859
23JBH552
23LBV456
24DBM081
24EBS504
24FBR479
DYNJ47645C
UDI-DI 10195327355173 (EA) 40195327355174 (CS)
LOTS 23IMH312
23LMD467
24BMB620
24DMD512
24FMF757
24GMD538
24JMC369
24KMB831
24LMD945
DYNJ47782G
UDI-DI 10195327495640 (EA) 40195327495641 (CS)
LOT 24GMA622
DYNJT2201S
UDI-DI 10195327263003 (EA) 40195327263004 (CS)
LOT 23HMG629
DYNJ33415A
UDI-DI 10888277792555 (EA) 40888277792556 (CS)
LOT 24CBG963
DYNJ64877B
UDI-DI 10193489415896 (EA) 40193489415897 (CS)
LOTS 23CBF259
23HBM117
23HBO973
23KBD360
23LBG859
24ABB266
24CMJ034
24FMD963
24HMH185
24JMD105
DYNJ65925D
UDI-DI 10195327531188 (EA) 40195327531189 (CS)
LOT 24DLA029
DYNJ44100M
UDI-DI 10195327324988 (EA) 40195327324989 (CS)
LOTS 23IMG347
23JMI669
23LME170
24AMI085
24CMA877
24CMJ446
24DME309
24FMC387
24FMC900
24FMF012
24FMH007
24GMC363
24HMF632
24JMF664
24LMD487
DYNJ0516014AG
UDI-DI 10195327271640 (EA) 40195327271641 (CS)
LOTS 23BME190
23DMH005
23KMH805
23KMI253
23LMH275
24AMH347
24CMI868
24DMI402
24DMK427
24EMG633
24IMB650
24IMJ127
24KMC298
DYNJ41556F
UDI-DI 10193489968170 (EA) 40193489968171 (CS)
LOTS 23IME423
23IMH983
DYNJ68365D
UDI-DI 10195327525040 (EA) 40195327525041 (CS)
LOT 23JBH517
DYNJ907758D
UDI-DI 10195327351335 (EA) 40195327351336 (CS)
LOTS 23FBP055
23HBC362
23HBL227
23HBX060
23KBB106
24CBT278
24CBV291
24HBE808
24HBR182
DYNJ907758F
UDI-DI 10198459128622 (EA) 40198459128623 (CS)
LOTS 24JBM379
24KBC281
DYNJ907960C
UDI-DI 10195327347451 (EA) 40195327347452 (CS)
LOT 24CBT833
DYNJ42557B
UDI-DI 10889942135806 (EA) 40889942135807 (CS)
LOT 24BBA461
DYNJ61411
UDI-DI 10193489562705 (EA) 40193489562706 (CS)
LOT 23GBH973
DYNJ61411A
UDI-DI 10195327483234 (EA) 40195327483235 (CS)
LOTS 23IBH456
23JBN809
DYNJ61411B
UDI-DI 10195327628697 (EA) 40195327628698 (CS)
LOTS 24DBE155
24LBE209
DYNJ80160
UDI-DI 10195327013226 (EA) 40195327013227 (CS)
LOT 24CBJ103
DYNJ40952B
UDI-DI 10195327203726 (EA) 40195327203727 (CS)
LOTS 24EBT279
24GBQ711
24HBR555
24JBO326
24LBM313
DYNJ61383B
UDI-DI 10193489751277 (EA) 40193489751278 (CS)
LOTS 23FLA104
23HLA490
23ILB095
23KBP994
23LBD911
24ALA301
DYNJ54762D
UDI-DI 10195327031725 (EA) 40195327031726 (CS)
LOT 24ABX637
DYNJ55338B
UDI-DI 10193489859027 (EA) 40193489859028 (CS)
LOT 22GMG972
DYNJ69246A
UDI-DI 10198459178931 (EA) 40198459178932 (CS)
LOTS 24LBA791
25ABA813
25CBF356
25DBA846
DYNJ52606F
UDI-DI 10193489343298 (EA) 40193489343299 (CS)
LOTS 23ELB102
23GLA496
23HLB190
23JLA642
23JLB201
24BLA295
24DLA690
24FLA227
24GLA493
24HLA557
24ILA766
24KLA315
DYNJ49802C
UDI-DI 10193489461602 (EA) 40193489461603 (CS)
LOT 24BBD110
DYNJ57512
UDI-DI 10889942748273 (EA) 40889942748274 (CS)
LOT 24ABS819
DYNJ58063 10889942816675 40889942816676 24ABM343
DYNJ84953 10195327440299 40195327440290 24FBM720 |
| 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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