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RecallWatchMedical Device Safety
Class IIOngoingZ-2585-2026

Medline Industries, LP recalls Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA…

Medline Industries, LPNorthfield, IL, United StatesReported Jul 1, 2026 · 17 days ago
Legal News Analyst ·

Reason for recall

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACKDYNJ56260B
    UDI-DI 10193489925067
    195 affected lots
    24BME75000-402001S1088994289364521ABV06321BBK29621OBA437DYNJ0842516F10193489352375
    +187 more21BDB24221CDC06321HDB97021IDB39521KDC35522BDA15722DDB62822FDA33122GDB353PHS463660F1019532709699122BBT65222DBK236DYNJ43580C1088994224939821BDB71021DDB799DYNDA2213A1088994292542123LBC294DYNJ65277A1019348940953624BBD60924BBD609ADYNJ0842793F1019348934523021CDA19121CDC09221EDA76921GDB28921HDC82222BDB29522DDA79222EDB72522IDC164DYNJ679181019348945908121ABP63021DBL45921EBD90521HBE28021HBE28521IBS95921VBD188DYNJ56666B1088827774027321BMB70021CMA789DYNJ44123A1088994295297721ABV98221CBB91621HBQ74021KBE93621VBC81622ABS46122CBX35422DBD60822EBT32222GBR52622HBS11922LBA93722LBM27823ABJ75823BBG29223CBD680DYNJ51126B1019532704413822ADA96122BDC24122DDA32022DDB65222FBD04722FBH29322HBQ22322HBY53522JBG518PAIN14541019348968886321CBA98521DBU96921FBN49521GBG63621KBJ91922ABJ58322BBN24322IBT75322KBA57023ABK22623IBE55223JBF41923KBJ152DYNJ905160I1019348939748221BBE98721DBD05821EBC916DYNJ0843063J1019348934537721CDA23321EDC22021GDC68221IDA57021JDA06421LDA15122ADC13622CDB16622EDA61622FDB83622HDB15022KDA481DYNJ37304F1088994272791923KMI510DYNJ56386B1088827776288621CBX17021GBQ83721JBW25321LBH79722ABX25922BBC24622CBW02622DBU97022GBA19522HBL09422LBH82923ABG50323ABO27423BBO05623DBQ67523FBQ67023HBV11523JBC74923JBP144DYNJ9077581019348987200221FBF623DYNJ409521088438989882621FBK360DYNJ607151019348952027924ABO126DYNJ37484B1088994277779221BDA45921DDA54921DDB64821GDC97521IDB97221JDC47521LDB20522ADC25622BDB58122FDA10022GDB22022IDB95322KDB83623ADA66123CDB42023DDC200DYNJ908706A1019532740604223FMI17323GMB99123HMF41023IMF032DYNJ0101339J1019348947251621BDA98521DDB91921GDD03521HDC81721KDA16222ADA29322BDB84922EDB04422HDB14822IDC162DYNJ690901019348988359621FMF06822EMB610DYNJ56260B1019348956982724ABR394

What the firm is doing

This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.

DistributionShow details

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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