Medline Class II Syringe Recall, 270,311 Units
Summary
FDA classified a Class II device recall for Medline Industries convenience kits containing 10mL Polycarbonate Colored Syringes affecting 270,311 units. The recall was initiated by the firm on February 27, 2026, after identifying unapproved design changes to the products made outside the 510(k) clearance process. Affected products span 38 distinct SKU numbers across multiple product lines including angiography packs, cardiac catheterization packs, craniotomy packs, and vascular access packs.
What changed
FDA classified a Class II recall for Medline Industries LP convenience kits containing 10mL Polycarbonate Colored Syringes after the firm determined it made unapproved design changes to the products outside of 510(k) clearance. The FDA-determined cause is component change control failure. Affected products include 38 SKU numbers across general surgery trays, angiography packs, cardiac catheterization packs, and other procedural kits with specific lot numbers and UDI-DI codes.
Healthcare providers using these Medline convenience kits in surgical or interventional procedures should verify their inventory against the affected SKU and lot number list to identify potentially impacted stock. Facilities that have distributed these kits should check their recall status and coordinate with Medline for return or replacement. This recall highlights the importance of maintaining 510(k) clearance scope when making component changes to cleared device combinations.
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-1890-2026 |
| Recall Event ID | 98601 |
| 510(K)Number | K213481 |
| Product Classification | General surgery tray - Product Code LRO |
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes |
ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M
ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K
ANGIO KIT PACK DYNJ83746B
ANGIO TRAY NO LIDO DYNJ85557A
ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T
ARTERIOGRAM NEURO PACK-LF DYNJ0842499L
ARTERIOGRAM PACK-LF DYNJ0842478M
CARDIAC CATH II PK DYNJ21259O
CARDIAC CATH PACK DYNJ68653D
CATH LAB ANGIOGRAPHY PACK DYNJ50779G
CATH LAB-LF DYNJ51423G
CRANIOTOMY PACK-LF DYNJ0101292I
DEEP BRAIN STIMULATION PACK DYNJ0842793I
ENDO VASCULAR MINOR DYNJ87263
GENERAL ENDO PACK-LF DYNJ0842873L
LEFT HEART DYNJ45984J
LIPO PACK DYNJ87218
MAA Y90 TRAY DYNJ82191D
MAIN OR CATH LAB DYNJ61373B
MINIMALLY INVASIVE PACK-LF DYNJ0843063M
NEURO CERVICAL PACK DYNJ0101287M
NEURO RADIOLOGY RICHMOND DYNJ68365F
NEURO VP SHUNT PACK-LF DYNJ0843121L
NON-VASCULAR PACK DYNJ56386C, DYNJ56386D
OR ANGIOGRAM PACK-LF DYNJ83656A, DYNJ83656B
OR RADIOLOGY PACK DYNJ62747A
PERCUTANEOUS ARTERIAL CATH PK DYNJ30551J
PERIPHERAL ARTERIOGRAM RAD DYNJ61383C
PICC ABSCESS PACK-LF DYNJ0774005I
PICC TRAY DYNJ30554I
PODIATRY PACK DYNJ46333G
POSTERIOR SPINE PACK-LF DYNJ0843339P
RRMC ANGIO PACK DYNJ36338D
SPECIAL PROCEDURE PACK DYNJ88258
VASCULAR ACCESS PACK-LF DYNJ0101291G
VASCULAR HYBRID DYNJ57543K
VASCULAR PACK DYNJ82220D
VISCERAL ANGIOGRAM PACK-LF DYNJ0429121M
WPH EP PACK DYNJ62745A |
| Code Information | DYNJ0429339L
UDI-DI 10195327586508 (EA) 40195327586509 (CS)
LOTS 24BMG223
24DMG627
DYNJ0429339M
UDI-DI 10198459021541 (EA) 40198459021542 (CS)
LOTS 24GMH043
24HMK218
DYNJ0774026K
UDI-DI 10198459053115 (EA) 40198459053116 (CS)
LOTS 24FBR752
24GBE275
24HBJ727
24IBD206
24KBB390
24KBT291
DYNJ83746B
UDI-DI 10198459077760 (EA) 40198459077761 (CS)
LOTS 24HBB576
24JBF419
24LBG659
DYNJ85557A
UDI-DI 10195327657901 (EA) 40195327657902 (CS)
LOT 24HBT042
DYNJ17218S
UDI-DI 10195327617547 (EA) 40195327617548 (CS)
LOTS 24ADC205
24DDA061
DYNJ17218T
UDI-DI 10198459014956 (EA) 40198459014957 (CS)
LOTS 24FDA217
24GDB466
24IDB458
DYNJ0842499L
UDI-DI 10198459119248 (EA) 40198459119249 (CS)
LOT 24LDB079
DYNJ0842478M
UDI-DI 10198459119255 (EA) 40198459119256 (CS)
LOT 24LDB078
DYNJ21259O
UDI-DI 10195327666323 (EA) 40195327666324 (CS)
LOTS 24EBQ265
24EBQ331
24KBG416
24LBP987
DYNJ68653D
UDI-DI 10198459123122 (EA) 40198459123123 (CS)
LOTS 24IBI799
24JBJ553
24KBT807
24LBQ652
DYNJ50779G
UDI-DI 10195327686499 (EA) 40195327686490 (CS)
LOTS 24GMA788
24HMA312
24IMI472
24KMC197
DYNJ51423G
UDI-DI 10198459022395 (EA) 40198459022396 (CS)
LOTS 24FLA167
24HLA548
24HLA720
24JLA538
DYNJ0101292I
UDI-DI 10198459119064 (EA) 40198459119065 (CS)
LOTS 24JDA749
24KDB872
24LDA883
DYNJ0842793I
UDI-DI 10198459119095 (EA) 40198459119096 (CS)
LOTS 24IDA565
24JDB658
DYNJ87263
UDI-DI 10198459026263 (EA) 40198459026264 (CS)
LOTS 24GMF532
24KME090
DYNJ0842873L
UDI-DI 10198459119163 (EA) 40198459119164 (CS)
LOTS 24JDB216
24KMI624
DYNJ45984J
UDI-DI 10198459072499 (EA) 40198459072490 (CS)
LOTS 24HMD351
24IMJ054
DYNJ87218
UDI-DI 10198459018800 (EA) 40198459018801 (CS)
LOTS 24GBA517
24IBO012
24LBT366
DYNJ82191D
UDI-DI 10198459099755 (EA) 40198459099756 (CS)
LOTS 24HMI555
24IMF587
24KMD232
DYNJ61373B
UDI-DI 10195327591298 (EA) 40195327591299 (CS)
LOTS 23LBS736
24ABA334
24KBF375
24LBM612
DYNJ0843063M
UDI-DI 10198459119460 (EA) 40198459119461 (CS)
LOTS 24LDB299
DYNJ0101287M
UDI-DI 10198459119491 (EA) 40198459119492 (CS)
LOTS 24JDA631
24KDB258
DYNJ68365F
UDI-DI 10198459130038 (EA) 40198459130039 (CS)
LOTS 24LBA409
24LBJ115
24LBJ634
DYNJ0843121L
UDI-DI 10198459119507 (EA) 40198459119508 (CS)
LOTS 24JMB397
24JMF145
DYNJ56386C
UDI-DI 10195327571252 (EA) 40195327571253 (CS)
LOTS 23LBI856
24CBJ902
24FBG624
24FBI743
24FBO911
24HBM314
DYNJ56386D
UDI-DI 10198459123382 (EA) 40198459123383 (CS)
LOTS 24JBX744
24KBH891
24LBS655
DYNJ83656A
UDI-DI 10195327600006 (EA) 40195327600007 (CS)
LOTS 24DMF381
24GMG344
DYNJ83656B
UDI-DI 10198459119538 (EA) 40198459119539 (CS)
LOT 24KMF093
DYNJ62747A
UDI-DI 10195327576530 (EA) 40195327576531 (CS)
LOTS 24EBI547
24FBR560
24IBG783
24LBK728
DYNJ30551J
UDI-DI 10198459131004 (EA) 40198459131005 (CS)
LOTS 24LLA323
25HLA222
DYNJ61383C
UDI-DI 10195327593346 (EA) 40195327593347 (CS)
LOTS 24CLA801
24DLA314
24ELA254
24FLA499
24GLA460
24HLA582
24HLB160
24JLB130
24KLB068
24LLA374
25ALA225
25ALB027
25CLA749
25DLA276
25GLA032
25ILA468
25JLA750
DYNJ0774005I
UDI-DI 10198459053184 (EA) 40198459053185 (CS)
LOTS 24GBE276
24HBS310
DYNJ30554I
UDI-DI 10198459131011 (EA) 40198459131012 (CS)
LOTS 24LLB049
25HLA223
25HLA971
DYNJ46333G
UDI-DI 10195327542320 (EA) 40195327542321 (CS)
LOT 24ABS351
DYNJ0843339P
UDI-DI 10198459119330 (EA) 40198459119331 (CS)
LOTS 24JDC273
24LDA042
DYNJ36338D
UDI-DI 10195327624002 (EA) 40195327624003 (CS)
LOTS 24BMJ645
24CMG670
24DMC608
24EMH999
24FME392
24JMD753
24JMI596
24KME048
24LMA450
DYNJ88258
UDI-DI 10198459133114 (EA) 40198459133115 (CS)
LOT 24JBB074
DYNJ0101291G
UDI-DI 10198459119439 (EA) 40198459119430 (CS)
LOTS 24IDB422
24KDB372
DYNJ57543K
UDI-DI 10198459004124 (EA) 40198459004125 (CS)
LOTS 24FMI037
24GMF547
24IMA891
24JME621
DYNJ82220D
UDI-DI 10198459103377 (EA) 40198459103378 (CS)
LOT 24LMC859
DYNJ0429121M
UDI-DI 10195327675813 (EA) 40195327675814 (CS)
LOTS 24DMA039
24DMG180
24EMH743
24IMF503
DYNJ62745A
UDI-DI 10195327686222 (EA) 40195327686223 (CS)
LOTS 24KBR735
24LBK675 |
| 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. | |
| 510(K) Database | 510(K)s with Product Code = LRO |
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