Recall events
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Event 98601
Event summary
Timeline bucket February 27, 2026
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Medline Industries, LP
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
17 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 17
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
Z-1876-2026
Recall number Z-1876-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1876-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29284]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
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 ***Updated 5/20/26 - The following lots were included in the customer notification but not in the FDA submission.*** DYNJ0220880V Lots 21DLA453 21FLA083 21ILA147 21KLA059 22ALA849 22DLA707 22FLA700 22HLA272 22ILA188 22ILA237 22ILA641 22JLA662 22KLA836 22KLA939 22LLA399 25KMB595 25LMA384; DYNJ30077D Lots 21ABB348 21ABR327 21DBQ397 21FBM873 21GBL539 21IBB390 21JBO220 21KBC302 21KBV079 21LBT528 22ABZ834 22DBD744 22EBG375 22JBK533 22KBO291 22OBM411 23ABD824 23ABO419 23DBB788 23EBS951 23HBB563 23IBG762 23JBT149 24CBR583; DYNJ32555C Lots 21DMA301 21DMD929 21EMB686 21FMA163 22KMD644 23AMB073 24LMH114 25BMA103 25BMD349; DYNJ46153B Lots 21CBL359 21FBE618 21GBF346 21HBQ716 21IBW154 21KBI853 21LBA401 22ABE877 22BBW978 22CBU323 22EBN725 22FBQ420 22GBJ229 22HBD581 22IBL258 22JBM061 22KBD440 22NBA199 23ABG769 23BBE724 25BBR850 25EBA187; DYNJ47710C Lots 21CBM120 21GBL622 21KBA849 21KBA925 22ABX239 22CBP654 22JBI023 22LBR933 23BBT611 25BBF414 25CBJ501; DYNJ61015B Lots 21AMB131 21BMB923 21BMC128 21CMD384 21DMD441 21FMD102 21GME205 21JMG652 22AMD050 22AME244 22DME869 22FMA872 22FMD246 22GMG534 22IMB779 22IMF574 22JMG963 23AMD815 23BMB886 23DMC707; DYNJ66631 Lots 21IBH359 21VBC892 22BBW852 22DBJ281 22EBJ532 22GBA380
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39007]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 17
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246
Z-1877-2026
Recall number Z-1877-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1877-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11766]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ0373221P UDI-DI 10195327506575 (EA) 40195327506576 (CS) LOTS 24ABR861 DYNJ0516014AI UDI-DI 10198459246234 (EA) 40198459246235 (CS) LOTS 25BME135 25EMI244 DYNJ0545064AA UDI-DI 10195327327385 (EA) 40195327327386 (CS) LOTS 23CMD735 24BMA467 24CME416 24DMG231 24EMI752 24FMD170 24HMD253 24JMC552 24LMA043 25AMJ675 25CMB252 25EMD050 25EMF726 DYNJ0854485X UDI-DI 10195327450366 (EA) 40195327450367 (CS) LOTS 23GMA609 23HMF271 23IMH767 23JMI189 23LMH350 24DMC322 24FMB078 24HMA888 24HMJ182 24LMB120 DYNJ17218R UDI-DI 10195327459642 (EA) 40195327459643 (CS) LOTS 23GDA609 23HDB136 23IDB699 23KDA473 DYNJ28082I UDI-DI 10195327429713 (EA) 40195327429714 (CS) LOTS 23HBC876 23KBE157 24BBC678 24DBN465 24FBQ528 24GBO066 24HBF409 24KBG843 DYNJ30565G UDI-DI 10195327140687 (EA) 40195327140688 (CS) LOTS 22DDB753 22FDB429 22HDB442 22KDA279 22LDB909 23BDB812 23EDA339 23GDA440 23IDA647 23IDB341 23KDB268 24BDA252 24CDB812 24EDC035 24HDC110 24IMA915 24JMI363 24KMG704 24LMF893 DYNJ36752B UDI-DI 10195327226022 (EA) 40195327226023 (CS) LOT 23IMD713 DYNJ37211J UDI-DI 10195327363673 (EA) 40195327363674 (CS) LOTS 24ABL975 24BBM554 24DBA215 24EBF356 24FBR841 24HBF463 24IBV426 24KBC581 24LBM346 DYNJ37389P UDI-DI 10195327201418 (EA) 40195327201419 (CS) LOTS 23DBO927 23FBC559 23GBF169 23GBJ160 23IBM982 DYNJ37389Q UDI-DI 10195327531270 (EA) 40195327531271 (CS) LOTS 23KBL184 23LMC983 23LMG114 24AME115 24BMJ169 24CMB351 24CMI800 24FMH298 24GMH700 24HMH956 24IMI993 24KMF785 24LMF430 DYNJ37485D UDI-DI 10195327397333 (EA) 40195327397334 (CS) LOTS 23DBP804 23FBH420 23GBF219 23HBJ487 23IBO358 23KBA337 23LBC194 24ABI270 24CMD265 24CMG190 24EMJ851 24GMK004 24HMF977 24JMC975 24KMH243 24LMG715 DYNJ37724K UDI-DI 10195327531256 (EA) 40195327531257 (CS) LOTS 23JBS842 23LMF451 24BMH462 24EMI397 24EMJ503 24GMK100 24HMH553 24JMA589 24KMJ234 DYNJ38395G UDI-DI 10195327286767 (EA) 40195327286768 (CS) LOTS 22LMF926 23BMA411 23DMD076 23DMG120 DYNJ44293F UDI-DI 10195327265182 (EA) 40195327265183 (CS) LOTS 23CBH106 DYNJ44293G UDI-DI 10195327427276 (EA) 40195327427277 (CS) LOTS 23HBI186 23HBX788 23IBP108 23JBQ388 23JBT471 23KBX452 23LBU382 24ABH531 24ABU590 24CBQ251 24FBS495 24HBB684 DYNJ44293J UDI-DI 10198459252471 (EA) 40198459252472 (CS) LOTS 25ABS436 25CBC411 25DBS739 25EBN111 25GBK945 DYNJ47665F UDI-DI 10195327355210 (EA) 40195327355211 (CS) LOTS 23GMI750 23IMG679 DYNJ47665G UDI-DI 10195327535810 (EA) 40195327535811 (CS) LOTS 23KMC220 23LMD957 24AMH318 24CMC513 24CMF048 24EMF765 24FMB398 24GMD088 24HMG619 24KMC285 DYNJ51126C UDI-DI 10195327299996 (EA) 40195327299997 (CS) LOTS 24EBL991 24GBL127 24HBB815 24IBI837 24KBT622 DYNJ51239C UDI-DI 10195327663728 (EA) 40195327663729 (CS) LOTS 24FBM878 DYNJ51697C UDI-DI 10195327517267 (EA) 40195327517268 (CS) LOTS 24HBJ453 24JBQ619 24KBL433 DYNJ55359C UDI-DI 10198459167447 (EA) 40198459167448 (CS) LOTS 24JBW626 24LBJ492 25ABM557 DYNJ55359D UDI-DI 10198459253584 (EA) 40198459253585 (CS) LOTS 25CBJ836 25EBB180 25FBC620 DYNJ56666D UDI-DI 10195327366780 (EA) 40195327366781 (CS) LOTS 23FMB079 23HMC084 23JMH176 DYNJ57723C UDI-DI 10195327533007 (EA) 40195327533008 (CS) LOT 24GMA688 DYNJ62595C UDI-DI 10195327386511 (EA) 40195327386512 (CS) LOTS 23FBD527 23FBK131 DYNJ62595D UDI-DI 10195327482626 (EA) 40195327482627 (CS) LOTS 23IBD384 23JBT585 23KBV027 23LBS746 24ABX161 24BBA663 24DBO214 24EBN761 24GBJ844 24IBT077 24JBX775 24KBR861 DYNJ62858C UDI-DI 10195327265212 (EA) 40195327265213 (CS) LOTS 23GMB070 24BMD149 24HMA369 24HMJ618 24JME908 DYNJ63434D UDI-DI 10195327611200 (EA) 40195327611201 (CS) LOTS 24BBU728 24CBK568 24FBE982 24GBP703 24HBS440 24JBD723 24JBN341 24LBQ810 DYNJ65162B UDI-DI 10195327443948 (EA) 40195327443949 (CS) LOTS 23KBA866 23LBL832 DYNJ66366D UDI-DI 10195327493387 (EA) 40195327493388 (CS) LOTS 23LMC414 24BMD428 24EMG916 24EMJ523 24GMC227 24GMG298 24GMI398 DYNJ66366F UDI-DI 10198459033117 (EA) 40198459033118 (CS) LOTS 24HMI310 24IMB847 24IMD381 DYNJ66631A UDI-DI 10195327225193 (EA) 40195327225194 (CS) LOTS 23ABB849 23ABP692 23BBP518 23HBN017 23IBO135 24BBU796 24EBA783 24GBD375 24HBG027 24IBG782 24JBU401 24KBH848 24LBE218 DYNJ68653B UDI-DI 10195327475970 (EA) 40195327475971 (CS) LOTS 23IBO333 23JBE362 23KBS420 DYNJ68653C UDI-DI 10195327626570 (EA) 40195327626571 (CS) LOTS 24BBU897 24EBB962 24EBJ449 24FBR693 24HBB850 DYNJ69200A UDI-DI 10195327489410 (EA) 40195327489411 (CS) LOTS 23IMC515 24AMD850 24DMH188 24FMF806 24JMF887 24JMJ455 DYNJ69997A UDI-DI 10195327260385 (EA) 40195327260386 (CS) LOTS 23KBU803 23LBM407 24ABP852 24BBV440 24DBE698 24EBF945 24FBD806 24FBO409 24HBD424 24IBA964 24JBH315 24KBF590 DYNJ82434 UDI-DI 10195327195991 (EA) 40195327195992 (CS) LOTS 23EBW505 23HBD267 23KBT910 DYNJ83506A UDI-DI 10195327366186 (EA) 40195327366187 (CS) LOTS 23FBD320 23GBC962 23HBI399 23JBR658 23LBG496 24ABV721 24CBC537 24CBU407 24EBC887 24FBC272 24GBS961 24HBQ313 24JBA160 24JBW202 DYNJ83516 UDI-DI 10195327277017 (EA) 40195327277018 (CS) LOTS 23FBR130 24EBL005 24FBG676 24GBO653 DYNJ83746 UDI-DI 10195327300692 (EA) 40195327300693 (CS) LOTS 23FBJ158 DYNJ83746A UDI-DI 10195327450199 (EA) 40195327450190 (CS) LOTS 23LBO128 24DBN523 24EBC851 24FBC179 DYNJ83812 UDI-DI 10195327310097 (EA) 40195327310098 (CS) LOTS 23GBU635 23HBC113 23JBX909 DYNJ85258 UDI-DI 10195327485696 (EA) 40195327485697 (CS) LOT 24CBQ941 DYNJ85557 UDI-DI 10195327516802 (EA) 40195327516803 (CS) LOT 23LBV118 DYNJ85557B UDI-DI 10198459140099 (EA) 40198459140090 (CS) LOT 24LBL658 DYNJ85783 UDI-DI 10195327548858 (EA) 40195327548859 (CS) LOT 24BBB824 DYNJ88276 UDI-DI 10198459139963 (EA) 40198459139964 (CS) LOT 24JBP183 DYNJ907758C UDI-DI 10195327193836 (EA) 40195327193837 (CS) LOT 23CBJ259 DYNJ910293 UDI-DI 10195327618711 (EA) 40195327618712 (CS) LOT 24CBB990 24DBP431 24GBO286 24GBP221 24HBL812 24KBG045 24KBN510 24LBR413 25CBJ733 25DBD091 25DBM647 DYNJT2202U UDI-DI 10195327263010 (EA) 40195327263011 (CS) LOTS 23HME786 DYNJVB1075B UDI-DI 10195327254735 (EA) 40195327254736 (CS) LOTS 23JLA749 DYNJVB91148A UDI-DI 10198459182372 (EA) 40198459182373 (CS) LOTS 25DLA750 25ELB006 25GLA721 PHS677784013B UDI-DI 10195327498887 (EA) 40195327498888 (CS) LOTS 24HMG073 24IMA820 24IME550 24KMB118 DYNJ0774026J UDI-DI 10193489271645 (EA) 40193489271646 (CS) LOTS 23BME179 23CMH777 23EMG669 23FMD595 23HMB354 23IMH606 23JMA027 24ABV703 DYNJ31196G UDI-DI 10198459095610 (EA) 40198459095611 (CS) LOTS 24HBW974 24JBJ110 DYNJ30565F UDI-DI 10195327031961 (EA) 40195327031962 (CS) LOTS 21JDC595 21LDA804 22CDA234 DYNJ69200 UDI-DI 10193489906813 (EA) 40193489906814 (CS) LOTS 23DMF486 23EMF929 23FMF496 23GMB826 23GMI809 DYNJ21574K UDI-DI 10195327008970 (EA) 40195327008971 (CS) LOTS 23FLA441 23GLB169 23ILA271 23JLA395 23JLA665 23KLB042 23LLA789 24BLA140 24BLB079 24DLA079 24FLA280 DYNJ21574L UDI-DI 10198459094385 (EA) 40198459094386 (CS) LOTS 24HLA450 24HLA848 24ILA065 24JLA291 24KLA039 24KLA924 24LLA313 DYNJ26855G UDI-DI 10195327008956 (EA) 40195327008957 (CS) LOTS 22ABE569 22ABZ784 22BBD499 22EBM551 22FBP986 22JBT802 22OBH709 23BBT658 23EBR341 23KBC736 23LBP243 24BBH599 24BBU885 24DBH273 24EBA834 24FBD738 24GBF739 24GBW918 DYNJ26855I UDI-DI 10198459094392 (EA) 40198459094393 (CS) LOTS 24IBR372 24JBS600 24KBO719 DYNJ0664960D UDI-DI 10193489397031 (EA) 40193489397032 (CS) LOTS 24GBE748 24GBV256 24IBO585 24JBC423 24JBG501 24KBK205 DYNJ59898B UDI-DI 10195327037130 (EA) 40195327037131 (CS) LOT 23JBN221 DYNJ68653A UDI-DI 10195327095703 (EA) 40195327095704 (CS) LOTS 23BBS119 23EBK331 23FBG953 23GBQ487 DYNJ69150A UDI-DI 10195327046330 (EA) 40195327046331 (CS) LOT 24BBB818 DYNJ0545064Y UDI-DI 10193489469042 (EA) 40193489469043 (CS) LOTS 21CBO976 21DBA926 21FBO930 21HBC707 21HBQ780 21KBG377 21LBB707 21LBM663 22BBT446 22CBE190 22DMH122 22EMF009 22FMH972 22GMB541 22IME216 22KMD333 22LMG693 DYNJ28428F UDI-DI 10889942218448 (EA) 40889942218449 (CS) LOTS 23EBV379 23GBM428 23HBG542 23JBH720 23JBR648 24BBI852 24CBC564 24CBK578 24DBS782 24GBJ992 24HBR901 24JBO787 DYNJ80457 UDI-DI 10195327039417 (EA) 40195327039418 (CS) LOT 24ABT460 DYNJ51423F UDI-DI 10193489456813 (EA) 40193489456814 (CS) LOTS 23ELA935 23FLB069 23GLA872 23GLA983 23HLB130 23JLA430 23JLA961 23LLA538 DYNJ62595B UDI-DI 10193489930443 (EA) 40193489930444 (CS) LOT 23CBK312 DYNJ62983A UDI-DI 10193489324792 (EA) 40193489324793 (CS) LOTS 23CMD917 23IME947 DYNJ43580D UDI-DI 10193489922622 (EA) 40193489922623 (CS) LOTS 23EDB907 23FDB773 23IDB785 23JDA831 23LDA819 24ADB496 24CDA214 24EDB119 24FDB521 24GDB467 24IDA596 24JDA196 24JDB828 24JDC323 DYNJ57760C UDI-DI 10195327079390 (EA) 40195327079391 (CS) LOTS 23FMI541 23GMC743 23IMC143 23IMD071 23JMG748 24BMD271 24CMF285 24FMD857 24HMG516 24IMB711 24JMH057 DYNJ69318 UDI-DI 10193489930344 (EA) 40193489930345 (CS) LOT 23BME178 DYNJ53251J UDI-DI 10193489965469 (EA) 40193489965460 (CS) LOTS 23BBB184 23BBJ802 23CBF225 23KBH360 24ABB431 24BBQ972 24CBN146 24DBR758 24GBP113 24HBS157 24IBG551 24IBH388 24KBM359 DYNJ81557 UDI-DI 10195327122621 (EA) 40195327122622 (CS) LOT 24DBN954 DYNJ65312 UDI-DI 10193489266405 (EA) 40193489266406 (CS) LOT 24ABP045 DYNJ61373A UDI-DI 10195327014698 (EA) 40195327014699 (CS) LOTS 23GBF047 23KBD741 23KBL501 23LBL092 DYNJ58339A UDI-DI 10193489483147 (EA) 40193489483148 (CS) LOT 24DBG343 NG140A UDI-DI 10889942945474 (EA) 40889942945475 (CS) LOT 23IBK929 DYNJ62747 UDI-DI 10193489687149 (EA) 40193489687140 (CS) LOT 23JBI082 DYNJ42633C UDI-DI 10193489810493 (EA) 40193489810494 (CS) LOTS 23FMG920 23FMH918 DYNJ36338C UDI-DI 10193489915532 (EA) 40193489915533 (CS) LOTS 23DMH629 23FME052 23IME630 23JMI386 23KMB592 23LMI240 24AMI028 DYNJ65756A UDI-DI 10193489423273 (EA) 40193489423274 (CS) LOTS 23EBR170 23FBJ964 DYNJ69246 UDI-DI 10193489917970 (EA) 40193489917971 (CS) LOTS 23BBM275 24CBQ263 24DBM916 24DBR138 24EBJ938 24IBH260 24JBF386 24JBT909 ***Updated 5/20/26 - The following lots were included in the customer notification but were erroneously omitted from FDA submission.*** DYNJ0664960D Lots 22BMH371 22CMC415 22EMC395 22HMA045 22IMA207 22IMH395 22KMA148 22KME310 23AMF897 23BMA101 23CMC444 23DMI595 23FBT283 23FMB607 23HBG453 23IBJ858 23KBR740 24BBE411 25BBE129 25CBK692 25CBL405; DYNJ0774026J Lots 21AMC513 21JMF113 21JMG031 21KMH257 22BMG580 22CME054 22CMH215 22HMD856 22JMI033 23AMA912 23AMA913 23BMA919 23EMC120 23GMB529; DYNJ21574K Lots 21JLA945 21KLA853 22ALA604 22BLA248 22CLB146 22ELB114 22GLA930 22HLA111 22HLA273 22ILA326 22JLA709 22KLA738 23ALA838 23BLA577 23CLA743 23DLA672 23DLA862 23ELA433; DYNJ21574L Lots 25ABP571 25ALA224 25CBL413; DYNJ26855G Lots 22KBH184 22KBH187 22KBW271 23CBU979 23DBJ420 23FBV657 23HBV978; DYNJ26855I Lots 25ABS101 25CBP637; DYNJ28428F Lots 21ABE606 21ABX433 21DBY170 21FBJ513 21HBL286 21KBL869 21LBW789 22BBZ883 22EBL952 22FBL846 22HBD442 22IBK193 22KBA938 22OBH723 23ABO267 23BBO094 23DBR441; DYNJ30565F Lots 22ADB192; DYNJ36338C Lots 21FMA808 21HMA558 21JMB764 21KMB724 21KMG896 21LME033 22AMA454 22AMC503 22AMD333 22AMD669 22CME152 22DMA962 22FMF229 22GME871 22HMF490 22HMF491 22LMD108 22LMD109 23AMD169 23CMC655 23EMG065 23GMG999; DYNJ43580D Lots 21HDB002 21IDA328 22ADA853 22ADB914 22BDA682 22DDA018 22GDA604 22JDB108 22KDA603 22LDA587 23CDB423 23DDA524 23EDA193 23HDA952 25ADA786 25CDA860 25DDB647; DYNJ51423F Lots 21BMA533 21BMC382 21DMD570 21EME514 21FMF497 21HMF227 21IMG702 21JMF701 22AMB754 22CME045 22CMI781 22DME838 22ELA971 22EMD527 22HLA188 22HLB263 22ILA267 22JLA278 22KLA321 22LLA091 23BLA350 23BLA675 23BLA970 23DLA222; DYNJ53251J Lots 22ELA480 22FLA093 22FLA778 22HLB264 22ILA736 22KBM371 22LBG230 23DBA349 23EBF780 23FBO855 23IBF068; DYNJ57760C Lots 22AMB380 22AMF802 22AMG614 22CMI270 22EMF515 22IMC996 22IMD003 23AMB106 23DMB626 23EMI855 25BMA402 25BMF957 25DMB075 25EMF632; DYNJ59898B Lots 22GBM877; DYNJ61373A Lots 21JMC103 21KMF078 21LMG304 22FMA200 22HMF897 22LMI439 23AMC909 23BMA352 23DMI379; DYNJ62595B Lots 21GBI606 21IBQ183 21KBH759 21KBH852 22ABC865 22BBG092 22EBF374 22EBM342 22GBL120 22HBU026 22JBD037 22KBO462 23ABH032 23BBG807 23DBB324; DYNJ62983A Lots 21FME305 21GMA862 22CMB536 23CMF038; DYNJ68653A Lots 22BBY312 22DBQ489 22EBL391 22GBZ211 22HBD649 22IBL267 22JBU310 22LBS024 23BBI165; DYNJ69200 Lots 21FME681 21HMB876 21IMC917 21JMD933 21JMI310 21KME674 22AME702 22FMA061 22FME489 22HMC803 22IMF050 22KMD085; DYNJ69246 Lots 21GBF658 21IBF761 22BBR453 22DBG565 22DBL761 22DBQ762 22FBN799 22GBV212 22GBV631 22IBA366 22IBL998 22LBH201 23BBS113 23DBP363 23EBU262 23FBQ188 23FBU876 23HBC446 23IBR816 23JBM664 23JBY394 23LBD914 24ABW660; DYNJ69318 Lots 21HMA008 21JMF648 21KMB459 22AMB554 22DMG103 22GMF851 22HMF642 22LMI947; DYNJ0545064AA Lots 23DMD621 23EME923 23FMD499 23HMA183 23IMC062 23KMA689; DYNJ28082I Lots 23GBC376; DYNJ30565G Lots 25BMF623; DYNJ37211J Lots 23CBU820 23DBS754 23FBU325 23HBT944 23JBA287 23LBH723 25ABW234 25CBI624; DYNJ37389P Lots 22IBD442 22JBI417 22KBJ960 22LBM305 23ABG699 23BBO067 23CBW125 23HBP088 23HBX781; DYNJ37389Q Lots 25BMB454 25CMD795 25EMD467; DYNJ37485D Lots 25AMJ305 25CMA151; DYNJ44293F Lots 22KBD454 23ABF404 23BBA548 23BBK630 23EBI351; DYNJ44293G Lots 24FBI497; DYNJ47665F Lots 23DMB165; DYNJ51126C Lots 23ABM214 23BBP534 23EBS133 23HBE509 23HBJ990 23IBJ494 23JBW154 23KBL881 24ABQ378 24CBH872 25ABD115 25BBP620 25CBF365; DYNJ51697C Lots 23JBJ820 23JBV985 23KBK659 24ABY364 24ABY589 24CBI875 24DBS165; DYNJ56666D Lots 23CMG612; DYNJ62595C Lots 23GBR603; DYNJ62595D Lots 24ABW004 25ABM934; DYNJ62858C Lots 25DMH376; DYNJ63434D Lots 24ABQ391 25EBQ015; DYNJ66366D Lots 23IMF996 23IMH874; DYNJ66366F Lots 25AMI656 25BMG505 25DMH492; DYNJ66631A Lots 22JBI275 22KBD175 25ABG940 25BBC391 25CBL495 25EBL467; DYNJ69200A Lots 25CMC399; DYNJ69997A Lots 22JBJ752 22LBE072 23ABO318 23DBF723 23EBS260 23FBR213 23HBJ664 23HBR069 23IBU588 25ABC945 25ABM804; DYNJ82434 Lots 22GBI888 22JBH646 22KBS435 23ABP641 23BBU305 23DBN593; DYNJ83506A Lots 23DBB771 23IBW275 25ABQ327 25BBS217 25EBC671; DYNJ83516 Lots 23ABB567 25BBC442; DYNJ83746 Lots 23BBJ812 23DBO406; DYNJ83746A Lots 23HBP852 23IBQ994; DYNJ83812 Lots 23BBQ875 23IBQ978; DYNJ85557B Lots 25ABD786 25ABU479 25BBT267 25CBH200 25EBI339; DYNJ88276 Lots 25CBS899 25EBF002; DYNJ907758C Lots 22LBH052 23ABL480 23BBK917; DYNJT2202U Lots 23AMD707; PHS677784013B Lots 25BMA486 25BMI667 25CMG487 25EMJ834
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39069]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 17
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
Z-1878-2026
Recall number Z-1878-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1878-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[47087]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
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 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** DYNJ0516014AG Lots 22LMD393 23DMG745 23HMB539 23LMH275A; DYNJ0842516G Lots 22KDA699 22LDC077 23DDB550 23GDA061 23HDC455 23JDA626 23LDB990 25BMH951 25BMI475; DYNJ26783D Lots 21CBL983 21FBE677 21GBR689 21JBA358 21KBF796 21LBG769 22ABX397 22CBA514 22FBK918 22GBO115 22JBU884 22KBJ430 23ABN303 23BBN053 25ABH287 25ABV765 25BBE142 25CBE875; DYNJ40952B Lots 22HBH043 22JBJ979 23DBR448 23FBE598 23JBL097 23KBH476 24ABR924 25BBS344 DYNJ44100M Lots 23AMJ315 23CMH807 23EMG216 23EMG763 23GMH722 23HMF163 23LMC066 25BMB884 25CMC633 25EMG169; DYNJ47645C Lots 23CMB852 23DMB824 23FMB662 25AMC532; DYNJ52606F Lots 21AKA467 21DKA121 21GLA734 21HLA612 21ILA348 21JLA304 21LLA164 22ALA074 22ALA885 22BLA931 22DLA955 22FLA562 22HLA294 22ILB142 22JLA807 23BLA662 23CLA943 25ALA106 25CLA447; DYNJ61383B Lots 21CLA367 21FLA054 21GLA195 21JLA060 21LLA062 22CLA063 22CLA337 22DLA685 22DLB071 22ELB118 22JLA236 22KLA964 23ALA936 23CLA512 23ELA390 23FLA461 23GLA377 23JLB155 23KLA301 23KLA891 23LLA228; DYNJ61411 Lots 21LBN952 22LBD611 23EBB430; DYNJ61411B Lots 25ABI638; DYNJ61926 Lots 21GBD658 21GBL566 21HBD840 21LBC437 22BBW042 22DBC423 22DBD732 22FBA218 22FBE801 22IBJ796 22JBC580 22KBO429 23CBV820; DYNJ64877B Lots 21FBQ067 21HBI622 21JBJ094 21KBJ217 21KBY182 22BBX515 22DBS770 22FBJ150 22GBG601 22HBG389 22IBH792 22KBF545 22LBB678 23ABI442 23ABT369 23BBM722 23CBU312; DYNJ65925D Lots 23KLA302 24FLA113 24HLA304 24KLA472 25BLA348 25DLA829; DYNJ80160 Lots 24ABN644; DYNJ905291D Lots 23EBV965 23FBN523 23IBC601 23KBP627 24ABC741 24BBK009 24DBI116 24DBI720 24FBE328 24GBT122; DYNJ907758D Lots 23CBO746
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39357]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 17
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
Z-1879-2026
Recall number Z-1879-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1879-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41165]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ38587A UDI-DI 10193489754070 (EA) 40193489754071 (CS) LOTS 20BBF696 20EBH917 20FBW435 20HBM667 20JBF107 20KBW292 20LBS930 21EBB195 21FBR610 21GBS936 21GBS940 21JBU912 21KBP999 22ABX182 22EBI922 22GBZ788 22JBL031 23BBN160 DYNJ38587B UDI-DI 10195327397326 (EA) 40195327397327 (CS) LOTS 23DBP789 23FBM124 23HBW639 23JBN841 24ABG236 24CBM867 24FME120 24JMD066 24LME187 DYNJ30078D UDI-DI 10889942138647 (EA) 40889942138648 (CS) LOTS 23CBK546 23FBQ481 23IBQ435 23JBR634 23LBG856 24ABE287 24BBS264 24EBQ336 24GBJ987 24JBO830 DYNJ59108B UDI-DI 10198459138461 (EA) 40198459138462 (CS) LOT 24JBP861 ***Updated 5/20/26 - The following lots were included in the customer communication but not in the FDA submission.*** DYNJ30078D Lots 21EBD861 21IBM130 21IBV938 21IBV939 21IBV940 21LBB809 22ABZ810 22BBV614 22FBL865 22IBE477 22JBH508 22KBJ437 22OBC310 23BBT881 23EBK298; DYNJ38587B Lots 25BMB873; DYNJ59108B Lots 24LBT539
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39495]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 17
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
Z-1880-2026
Recall number Z-1880-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1880-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52831]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ0101278F UDI-DI 10193489352351 (EA) 40193489352352 (CS) LOTS 22CDB133 22EDA975 22FDA831 22HDC403 DYNJ0101278G UDI-DI 10195327286477 (EA) 40195327286478 (CS) LOTS 22KDB109 22LDA476 23CDA805 23DDB546 23EDC278 23FDC023 23JDA625 23KDB893 24ADB642 24BDB842 24CDB908 24GDA043 24IDA026 DYNJ0101278I UDI-DI 10198459119477 (EA) 40198459119478 (CS) LOT 24JDC169 DYNJ56262 UDI-DI 10889942624331 (EA) 40889942624332 (CS) LOT 24ABO125 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ0101278F lots 21ADC024 21CDA355 21EDA527 21GDC529 21IDA040 21IDA786 21JDB214 21KDC443 22ADC117 22GDA789; DYNJ0101278G lots 23HDC100; DYNJ0101278I lots 25AME306 25AMI354 25BMG147 25BMG147A
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39347]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 17
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599
Z-1881-2026
Recall number Z-1881-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1881-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29282]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ905153M UDI-DI 10195327556761 (EA) 40195327556762 (CS) LOT 24CMG485 DYNJ905153N UDI-DI 10198459017797 (EA) 40198459017798 (CS) LOT 25DMC254 DYNJ81602 UDI-DI 10195327123857 (EA) 40195327123858 (CS) LOT 24ABP080 DYNJ905157K UDI-DI 10195327556921 (EA) 40195327556922 (CS) LOTS 24DMF349 24EMC297 DYNJ905157L UDI-DI 10198459017711 (EA) 40198459017712 (CS) LOTS 24FMD083 24HMD400 24IME332 24JMA234 24KMG588 25AMA393 25AMJ541 25BMI202 25CMD909 25CMH371 DYNJ46675G UDI-DI 10195327419066 (EA) 40195327419067 (CS) LOT 24ABS814 DYNJ81607 UDI-DI 10195327123918 (EA) 40195327123919 (CS) LOT 24ABP097 DYNJ905160O UDI-DI 10198459017742 (EA) 40198459017743 (CS) LOTS 24HMG093 24IME714 24JMI924 24LMB556 25AME613 25BMJ076 DYNJ81599 UDI-DI 10195327124021 (EA) 40195327124022 (CS) LOT 24BBB847 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ905153M lots 24BMH968 24EMG682; DYNJ905153N lots 24HMG087 24IMA442 24IMG245; DYNJ905157K lots 23LME674 24AMH261 24AMJ205 24BME886 24CMD057
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39431]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 17
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Z-1882-2026
Recall number Z-1882-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1882-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52826]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ80343C UDI-DI 10195327507299 (EA) 40195327507290 (CS) LOT 24ABO127 DYNJ86639 UDI-DI 10195327661922 (EA) 40195327661923 (CS) LOT 24FBM972
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[701]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 17
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G
Z-1883-2026
Recall number Z-1883-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1883-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17701]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489546194 (EA) 40193489546195 (CS) LOTS 21FBT962 21HBE414 21JBK356 21LBU392 22HBH070 22IBD976 22OBF481 23ABS489 23BBT198 23EBR237 23GBH211 23IBP468 23JBC690 23KBJ782 23LBT261 24BBQ276 24DBG218 24EBQ703 24GBE940 24IBD970 24JBA173 24KBQ943 DYNJ44139C UDI-DI 10193489226102 (EA) 40193489226103 (CS) LOTS 21EBS091 21GBI562 21HBR793 21IBX717 21KBJ549 22ABH554 22BBM456 22DBS762 22FBJ076 22FBR590 22IBB384 22KBF481 22LBB630 22OBG108 23ABJ826 23BBO865 23CBR417 23DBN752 23EBV786 23GBR439 23IBE449 23IBU640 23KBJ599 23LBP229 24ABC062 24EMG282 24IMC574 DYNJ905160N UDI-DI 10195327664473 (EA) 40195327664474 (CS) LOTS 24DMC432 24EMG685 DYNJ35216C UDI-DI 10889942952618 (EA) 40889942952619 (CS) LOTS 22GDA210 24IDA943 24KDA980 24LDA479 DYNJ41941D UDI-DI 10193489753707 (EA) 40193489753708 (CS) LOTS 20ABB748 20ABV122 20BBA524 20CBN068 20EBG674 20FBD191 20HBS587 20JBT996 21ABI859 21ABJ490 21BBD481 21CBH747 21DBH332 21JBE257 21JBU827 21LBR129 22CBZ848 22FBK880 22IBT430 22KBT522 22OBG445 23BBB312 23CBR316 23DBO494 23GBQ439 23HBM965 23HBX738 23IBU090 23JBV457 23LBF066 23LBT768 24CBG494 24DBG816 24EBC719 24JBF955 24KBD843 DYNJ0774759P UDI-DI 10195327246136 (EA) 40195327246137 (CS) LOT 24DMH153 DYNJ42094B UDI-DI 10889942820849 (EA) 40889942820840 (CS) LOTS 24CDA087 24EDA493 24HDA294 24IDA278 24IDB151 24IME505 24JMF227 24KMC897 24LME897 DYNJ55063B UDI-DI 10195327538972 (EA) 40195327538973 (CS) LOT 24ABP065 DYNJ55359B UDI-DI 10193489235517 (EA) 40193489235518 (CS) LOTS 23DBI651 23FBR555 23GBK876 23HBC455 23IBC298 23KBN808 24BBO002 24DBG256 24DBQ490 24EBJ876 24GBO458 DYNJ908706C UDI-DI 10195327664497 (EA) 40195327664498 (CS) LOT 24EMG687 DYNJ41174A UDI-DI 10195327366254 (EA) 40195327366255 (CS) LOT 23JBK389 SAMPC0644 UDI-DI 10193489356885 (EA) 40193489356886 (CS) LOT 20FDA159 DYNJ62745 UDI-DI 10193489688160 (EA) 40193489688161 (CS) LOT 24ABQ796 DYNJ44295G UDI-DI 10195327431273 (EA) 40195327431274 (CS) LOT 24IBH033 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ35216C lots 21BDA005 21CDA164 21DDB532 21IDA938 21KDB822 22ADB494 22ADC166 22CDB658 22DDC504 22HDA355 22LDA336 23BDB027 23BDC034 23DDA002 23DDA917 23GDA443 23HDA139 23JDC163 23LDA319 24DDA760 24GDA206 24GDB408 25BDA073 25DDA617 25DDB847; DYNJ41941D lots 24LBU189 25EBO278; DYNJ42094B lots 21DDA142 21EDA157 21FDA721 21HDC553 21JDB308 21KDC411 22ADB304 22DDA696 22EDB388 22GDB457 22HDC130 22KDB833 23ADA446 23BDB104 23DDA367 23EDA799 23FDB379 23HDB674 23KDA291 23KDC457 24ADA586 25DMB689 25EMH157; DYNJ42136B lots 20XBH732 21FBD068 21FBP137 21GBM895 21IBO938 21JBW334 21LBK626 22DBB070 22DBT749 22DBT751 22GBL802 22KMB909 23AMA925 23AMA926 23DMC128 23EMK206 23FMD274 23GMI199 23IMF729 23KMG485 25DMG003 25EMJ002; DYNJ44139C lots 21ABF720 21BBP639 21OBA387 DYNJ46301C 23EMD296; DYNJ55359B lots 21CBY049 21HBJ347 21KBK603 21LBU329 22BBN805 22DBG945 22DBG946 22EBI619 22EBI620 22GBV248 22IBD917 22JBP712 22KBO285 22LBF294 23BBN404 23CBU106; DYNJ61006 lots 21BBM590 21DBE579 25EBA174; DYNJ62745 lots 21CBZ899 21EBI827 21HBB755 21KBR329 21LBP817 22BBB761 22BBY454 22FBG531 22FBG532 22GBH888 22HBH100 22JBS334 23ABF660 23BBR901 23DBC087 23EBN460 23FBQ453 23GBH068 23IBB014 23JBP276 23LBJ141 24BBR785 24BBS830; VASC1109 lots 25BBR047
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39433]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 17
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176
Z-1884-2026
Recall number Z-1884-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1884-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41162]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ50783B UDI-DI 10193489227376 (EA) 40193489227377 (CS) LOT 23FBF183 DYNJ37485C UDI-DI 10193489760002 (EA) 40193489760003 (CS) LOTS 20BBX692 20DBC089 20EBG816 20FBR153 20HBN288 20IBK578 20KBW291 21BBB266 21CBW198 21FBH674 21GBS840 21GBS842 21JBU703 21LBX721 22BBV337 22EBN708 22IBJ467 22JBH996 22KBU901 22OBJ150 23ABG615 23BBF603 23CBC306 DYNJ53064B UDI-DI 10193489789164 (EA) 40193489789165 (CS) LOT 23HMI416 DYNJ39931D UDI-DI 10193489459364 (EA) 40193489459365 (CS) LOTS 23BBB182 23DBK363 24HBJ427 24JBI915 24JBV985 24KBH817 25GBI670 25IBS445 DYNJ0948060F UDI-DI 10889942825103 (EA) 40889942825104 (CS) LOTS 23FMA240 24EBR693 24GLB224 24HLA705 24JLA904 NAM0003 UDI-DI 10193489222555 (EA) 40193489222556 (CS) LOTS 20DBO375 20GBC317 20GBJ719 20HBC159 20HBD815 20HBF519 20IBA514 23CMC981 23DMC490 23DMF161 23GMA353 23HME057 23HMG264 23IMF173 23JMF878 23JMH829 23KME885 23LMA780 23LMD088 23LMG059 24AMF167 24AMH128 24EMG747 24HMJ041 24JMC680 DYNJ61542D UDI-DI 10195327507923 (EA) 40195327507924 (CS) LOT 24FMC929 DYNJ59903B UDI-DI 10195327131203 (EA) 40195327131204 (CS) LOTS 23EBQ216 23HBC089 23IBE176 23KBL439 23LBO494 24ABL938 24CBQ708 24EBB108 24FBA584 24FBN897 24JBC983 24JBO349 24KBB061 24KBT242 24LBP491 DYNJ84872A UDI-DI 10195327481506 (EA) 40195327481507 (CS) LOTS 23LBN462 24ABC179 DYNJ44027F UDI-DI 10193489783490 (EA) 40193489783491 (CS) LOTS 21FLA184 21FLA910 21ILA783 21JLA542 21LLA177 22ALA731 22BLA802 22DLA497 22ELA818 22FLA432 22GLB161 22HLB062 22JBC795 22JBM045 22KBO209 22KBO210 23DBR512 23FBQ563 23GBK955 23HBY707 23JBT738 23KBF311 23KBU563 24ABW467 24GBK560 24HBB843 24IBI798 24IBR643 24JBF292 DYNJ62176 UDI-DI 10193489631784 (EA) 40193489631785 (CS) LOTS 23ELA677 23GLA263 23KLB156 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0948060F lots 21AMA919 21AMB491 21BMC178 21HMF800 21JMG472 22AMB406 22CMI927 22EMC824 22GMF261 22IMA651 22JMG952 22KME549 22LMD531 23AMD745 23AMJ626 23CMB808 23DMC060 23EMB613 23EMG672 23GMG693 23GMI438 23IMG055 23KBR802 24ABP567 25ALA622 25ALA678 25CLA317 25DLA949 25ELA692; DYNJ39931D lots 21ABW861 21CBY118 21DBN140 21HBN105 21KBO171 21LBP808 21LBP811 22CBY154 22FBA263 22JBU799 23BBR777 23BBT177 23EBS918 23FBO983 23GBR315 23GBW410 23HBJ976 23IBJ863 23KBC962 23LBU944 24ABK323 24ABP442 24BBH773 24GBO821; DYNJ44027F lots 21BLA158 21CLA034 21DLA700 25EBE984 25EBU842; DYNJ50783B lots 21DBL972 21FBK452 21GBA227 21IBA354 21JBO239 21KBP327 21LBB845 21LBU425 22DBC322 22DBN517 22EBK090 22FBK172 22HBU114 22KBQ551 22KBQ552 23BBJ725 23CBO941 23EBC283; DYNJ59903B lots 22EBI499 22FBF028 22FBR425 22IBJ538 22LBQ311 23ABN466 23CBJ596 23CBP099 25DBF626; DYNJ62176 lots 21ALA437 21BLA178 21BLA238 21BLA352 21CLA516 21GLB100 22ALA163 22BLB207 22ELB041 22KLA092 22LLA728 23ALA743 23BLA184 23KLB124 24BLA180 24ELA039 24JLA075; DYNJ84872A lots 23IBS046; NAM0003 lots 21BBF218 21CBE230 21DBV018 21EBS508 21GBI653 21KBO486 21LBB470 22CME110 22EMH496 25AMG212 25BMA481 25BMF357 25BMH684 25DMH014 25DMH503 25EMD617 25EMI879
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39065]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1885-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1885-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32772]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39492]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1886-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1886-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32770]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ69318A lots 23FMA845 23FMA924 25BMF603
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39132]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1887-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1887-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32766]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ34846C UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT 24BBA459 DYNJ83218A UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT 24BBD199 DYNJ85396 UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT 24BBA503 DYNJ905156R UDI-DI 10198459017704 (EA) 40198459017705 (CS) LOTS 24HBG726 24JBJ484 25ABS758 25BBR196 25CBN174 25EBE136 DYNJ905159L UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT 24EMB726 DYNJ905159M UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT 24GMA714 24HMD401 24HMJ945 24JMD201 24KMG592 25AMC024 25BMD945 25CMG373 DYNJ69926A UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT 24ABS445 DYNJ41250B UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT 24ABO122 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39427]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1888-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1888-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29287]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[581]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1889-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1889-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11770]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
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Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[771]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1890-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1890-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[47092]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
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 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0101287M lots 25BMC014; DYNJ0429121M lots 24GME309 25AMA768 25AMI616 25CMC127 25DME972 25EMH823; DYNJ0429339M lots 25AMI338 25BMI962 25DMG132; DYNJ0774005I lots 25ABU445 25EBJ726; DYNJ0774026K lots 25ABL910 25CBC859; DYNJ0842478M lots 25BMD033; DYNJ0842499L lots 25ADA394 25ADB067 25BDB213; DYNJ0842873L lots 25AMF044 25BMI157 25CMJ723; DYNJ0843063M lots 24KDA944 25BMC710 25CMB746; DYNJ0843121L lots 25BMA139 25BMG893; DYNJ0843339P lots 25AMC387 25BMI894; DYNJ30551J lots 25BLA948 25DLA390 25ELA675 25FLA636; DYNJ30554I lots 25BLB061 25CLA785 25FLA348; DYNJ36338D lots 25AMD997 25DMB069 25EMA091; DYNJ50779G lots 25BMC031 25BMF563 25CMI786 25DMH709; DYNJ51423G lots 25DLB019; DYNJ56386D lots 25BBK025 25DBL564; DYNJ57543K lots 25BMA534 25BMH775 25DMA332; DYNJ61373B lots 25BBD697 25CBH388 25EBE177; DYNJ62745A lots 24EBG787 24FBM384 24GBE754 24GBY096 24HBM688; DYNJ62747A lots 24LBU340 25ABC752 25CBD229 25DBH729; DYNJ68365F lots 25ABS737 25DBF630; DYNJ68653D lots 25BBB109 25EBI916; DYNJ82191D lots 25AMD097; DYNJ82220D lots 25AMG555 25BMG434; DYNJ83656A lots 24BMC933 24CMA913; DYNJ83656B lots 25AMB305 25BMH455; DYNJ87218 lots 25ABJ285 25BBK929
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39429]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1891-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1891-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17694]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
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 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** 00-402001T Lots 21GBL509 21JBN647 21JBZ697 22BBX248 22DBL467 22DBS962 22GBC939 22HBO291 22HBO322 22IBN444 22IBO023 22KBT315 23BBA151 23CBI235 23DBM140; DYNJ0774005G Lots 21AMC932 21CMB295 21EMA842 21EMA842Z 21GME190 21IMF074 21JMA971 22AMB224 22CMF849 22CMG025 22DMF774 22HMD145 22HMH991 22JMF788 23AMH034 23CMA447; DYNJ37484C Lots 23EDA007 23GDA068 23HDC049 23JDA140 23LDA212 24BDA222 24DDA235 25AMA456 25AMH943; DYNJ44123C Lots 25BMC026; DYNJ47717B Lots 23DME176; DYNJ68037B Lots 23JBM013 23LBR847 24CBM608 24DBQ050 24HBT816 25ABA997
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39348]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1892-2026
Initiated February 27, 2026
Classification Class II
Status Ongoing
Quantity 270,311 total
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
Unapproved design changes
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1892-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52829]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Unapproved design changes to the products outside of the 510(k) clearance.
Code information DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556
Distribution pattern Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[745]
FDA event record
· Exact recall-number query on openFDA
