CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Medline procedure kits labeled as: AV Fistula Pack, Pack Number recalled

Medline Industries LP - Northfield is recalling Medline procedure kits labeled as: AV Fistula Pack, Pack Number, distributed nationwide in the US. The recall was initiated on 11 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case), Lot Number 23DBG477A; 2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case), Lot Number 23LMD975A; 3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case), Lot Number 22GBV822Z; 4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case), Lot Number 22GMB113A; 5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case), Lot Number 21JMG551A; 6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case), Lot Number 23JBH403A; 7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case), Lot Number 21LBJ158A; 8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case), Lot Number 24AMF039A; 9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case), Lot Number 23LMF122A; 10) Pack Number DYNJ0810062AI: UDI/DI 10193489866049 (each) 40193489866040 (case), Lot Number 22CMB582A; 11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case), Lot Number 22JBD481Z; 12) Pack Number DYNJ59830A: UDI/DI 10193489570236 (each) 40193489570237 (case), Lot Number 21EMF434A; 13) Pack Number SYNJ10304B: UDI/DI 10193489786965 (each) 40193489786966 (case), Lot Number 21LBD584A; 14) Pack Number DYNJ53854A: UDI/DI 10193489631517 (each) 40193489631518 (case), Lot Number 21GMB561A; 15) Pack Number DYNJ30217G: UDI/DI 10193489922141 (each) 40193489922142 (case), Lot Number 23CBN679A; 16) Pack Number DYNJ56235: UDI/DI 10889942621552 (each) 40889942621553 (case), Lot Number 23EBD843A; 17) Pack Number DYNJ55482F: UDI/DI 10195327332273 (each) 40195327332274 (case), Lot Number 23BBS877A; 18) Pack Number DYNJ65916B: UDI/DI 10193489902044 (each) 40193489902045 (case), Lot Number 23JBT190A; 19) Pack Number DYNJ38059A: UDI/DI 10193489401110 (each) 40193489401111 (case), Lot Number 20LMF803A; 20) Pack Number DYNJ36931D: UDI/DI 10193489927559 (each) 40193489927550 (case), Lot Number 23BBS364Z; 21) Pack Number DYNJ60618C: UDI/DI 10193489475630 (each) 40193489475631 (case), Lot Number 22GMD148Z; 22) Pack Number CDS983376Q: UDI/DI 10195327379797 (each) 40195327379798 (case), Lot Number 23IBG370Z; 23) Pack Number DYNJ65226: UDI/DI 10193489253672 (each) 40193489253673 (case), Lot Number 20BDA909A; 24) Pack Number DYNJ59466A: UDI/DI 10193489562613 (each) 40193489562614 (case), Lot Number 21BBF996A; 25) Pack Number DYNJ900968I: UDI/DI 10193489453188 (each) 40193489453189 (case), Lot Number 22IBM300N; 26) Pack Number DYNJ54738C: UDI/DI 10193489778755 (each) 40193489778756 (case), Lot Number 21EBF317A; 27) Pack Number DYNJ63892A: UDI/DI 10195327176518 (each) 40195327176519 (case), Lot Number 23LME320A; 28) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22IBN057Z; 29) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22JBJ452Z; 30) Pack Number DYNJ905021J: UDI/DI 10195327281625 (each) 40195327281626 (case), Lot Number 23DBI088Z; 31) Pack Number DYNJ04478R: UDI/DI 10888277748835 (each) 40888277748836 (case), Lot Number 22GMA554A; 32) Pack Number DYNJ23533D: UDI/DI 10193489470659 (each) 40193489470650 (case), Lot Number 22GMC009A; 33) Pack Number CDS840171AB: UDI/DI 10195327167042 (each) 40195327167043 (case), Lot Number 22GMG011Z; 34) Pack Number DYNJ0382048N: UDI/DI 10195327537364 (each) 40195327537365 (case), Lot Number 23JBV598A; 35) Pack Number DYNJ45122C: UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 21EME856A; 36) Pack Number DYNJ55648: UDI/DI 10889942581900 (each) 40889942581901 (case), Lot Number 21LBN735A; 37) Pack Number DYNJ04381J: UDI/DI 10888277745155 (each) 40888277745156 (case), Lot Number 23GMB245A; 38) Pack Number DYNJ24300M: UDI/DI 10193489823608 (each) 40193489823609 (case), Lot Number 23FBL428A; 39) Pack Number DYNJ0369758N: UDI/DI 10193489501247 (each) 40193489501248 (case), Lot Number 22GBO541Z; 40) Pack Number DYNJ43038N: UDI/DI 10195327263911 (each) 40195327263912 (case), Lot Number 23EMD464A; 41) Pack Number DYNJ65641: UDI/DI 10193489282986 (each) 40193489282987 (case), Lot Number 21BBF660A; 42) Pack Number DYNJ67442B: UDI/DI 10195327133542 (each) 40195327133543 (case), Lot Number 23DBR515A; 43) Pack Number DYNJ59399I: UDI/DI 10195327442071 (each) 40195327442072 (case), Lot Number 23HMB191A; 44) Pack Number DYNJ0373237M: UDI/DI 10193489369014 (each) 40193489369015 (case), Lot Number 23LBU493Z; 45) Pack Number DYNJ66165: UDI/DI 10193489319729 (each) 40193489319720 (case), Lot Number 20DBP548A; 46) Pack Number DYNJ41134B: UDI/DI 10889942011643 (each) 40889942011644 (case), Lot Number 21BBI489A; 47) Pack Number DYNJ61260A: UDI/DI 10193489857481 (each) 40193489857482 (case), Lot Number 21HMF542A; 48) Pack Number DYNJ60635: UDI/DI 10193489518153 (each) 40193489518154 (case), Lot Number 21IMG997A; 49) Pack Number DYNJ42602C: UDI/DI 10195327019198 (each) 40195327019199 (case), Lot Number 23BBR329A; 50) Pack Number DYNJ32897J: UDI/DI 10193489648102 (each) 40193489648103 (case), Lot Number 20AKB914A; 51) Pack Number DYNJ39912B: UDI/DI 10889942705078 (each) 40889942705079 (case), Lot Number 21GMA579A; 52) Pack Number DYNJ53112B: UDI/DI 10193489650617 (each) 40193489650618 (case), Lot Number 21IMF023A; 53) Pack Number DYNJ51844B: UDI/DI 10889942615773 (each) 40889942615774 (case), Lot Number 21LME446A; 54) Pack Number DYNJ0854874R: UDI/DI 10195327094966 (each) 40195327094967 (case), Lot Number 22CMB704A; 55) Pack Number DYNJ54750G: UDI/DI 10195327021351 (each) 40195327021352 (case), Lot Number 22GBH035A; 56) Pack Number DYNJ22036F: UDI/DI 10889942528899 (each) 40889942528890 (case), Lot Number 20FBH674A; 57) Pack Number DYNJ44015B: UDI/DI 10193489215939 (each) 40193489215930 (case), Lot Number 23EMD927A; 58) Pack Number DYNJ45048C: UDI/DI 10193489808889 (each) 40193489808880 (case), Lot Number 21IMD394A; 59) Pack Number DYNJ0394805N: UDI/DI 10193489245240 (each) 40193489245241 (case), Lot Number 23LME396A; 60) Pack Number DYNJ33544L: UDI/DI 10195327279318 (each) 40195327279319 (case), Lot Number 23LMF755A; 61) Pack Number DYNJ0394730P: UDI/DI 10193489430943 (each) 40193489430944 (case), Lot Number 21LMG091A; 62) Pack Number DYNJ58386A: UDI/DI 10193489397468 (each) 40193489397469 (case), Lot Number 21VBB871A; 63) Pack Number DYNJ80309: UDI/DI 10195327023218 (each) 40195327023219 (case), Lot Number 23LMF645A; 64) Pack Number DYNJ45376G: UDI/DI 10195327209353 (each) 40195327209354 (case), Lot Number 23KMD075A; 65) Pack Number DYNJ48288C: UDI/DI 10888277745599 (each) 40888277745590 (case), Lot Number 21IMH225A; 66) Pack Number DYNJ54979: UDI/DI 10889942519910 (each) 40889942519911 (case), Lot Number 21LBL535Z; 67) Pack Number DYNJ64883C: UDI/DI 10193489369670 (each) 40193489369671 (case), Lot Number 23BBR373A; 68) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23GME703A; 69) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23HMC425A; 70) Pack Number DYNJ67426A: UDI/DI 10195327049317 (each) 40195327049318 (case), Lot Number 23HMC554A; 71) Pack Number DYNJ41863C: UDI/DI 10195327463632 (each) 40195327463633 (case), Lot Number 23HBW577A; 72) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 20EBI994A; 73) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 21BBI579A

Quantity recalled3860 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1438-2025
FDA event ID: 96374
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 11 Feb 2025
FDA classified: 25 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Pacemakers & Defibrillators

Timeline

11 Feb 2025	Recall initiated by company
25 Mar 2025	Classified by FDA	+42 days
2 Apr 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C; 6) CARDIAC CATH PACK, Pack Number DYNJ61256A; 7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527; 8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C; 9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F; 10) CAROTID PACK, Pack Number DYNJ0810062AI; 11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T; 12) CATH PACK, Pack Number DYNJ59830A; 13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B; 14) CICC, Pack Number DYNJ53854A; 15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G; 16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235; 17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F; 18) EP DEVICE, Pack Number DYNJ65916B; 19) EP STUDY PACK-LF, Pack Number DYNJ38059A; 20) FHZ PACEMAKER PACK, Pack Number DYNJ36931D; 21) GV OPEN HEART PACK, Pack Number DYNJ60618C; 22) HEART CABG CDS, Pack Number CDS983376Q; 23) HEART DRAPE & SUPPLY PACK, Pack Number DYNJ65226; 24) HH ARTERIOGRAM PACK, Pack Number DYNJ59466A; 25) LEX OPEN HEART, Pack Number DYNJ900968I; 26) MAJOR VASCULAR PACK SAFETY, Pack Number DYNJ54738C; 27) NIR PACK, Pack Number DYNJ63892A; 28) OPEN HEART, Pack Number DYNJ904261B; 29) OPEN HEART, Pack Number DYNJ904261B; 30) OPEN HEART, Pack Number DYNJ905021J; 31) OPEN HEART A PACK, Pack Number DYNJ04478R; 32) OPEN HEART ACC, Pack Number DYNJ23533D; 33) OPEN HEART CDS, Pack Number CDS840171AB; 34) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048N; 35) OPEN HEART PACK, Pack Number DYNJ45122C; 36) OPEN HEART PACK, Pack Number DYNJ55648; 37) OPEN HEART PACK, Pack Number DYNJ04381J; 38) OPEN HEART PACK & BASIN SET-LF, Pack Number DYNJ24300M; 39) OPEN HEART PACK-LF, Pack Number DYNJ0369758N; 40) OPEN HEART PART B PACK, Pack Number DYNJ43038N; 41) OPEN HEART SUPPLY, Pack Number DYNJ65641; 42) OPEN PACK, Pack Number DYNJ67442B; 43) PACEMAKER, Pack Number DYNJ59399I; 44) PACEMAKER IMPLANT PACK-LF, Pack Number DYNJ0373237M; 45) PACEMAKER PACK, Pack Number DYNJ66165; 46) PACEMAKER PACK, Pack Number DYNJ41134B; 47) PACEMAKER PACK, Pack Number DYNJ61260A; 48) PACEMAKER PACK, Pack Number DYNJ60635; 49) PACEMAKER PACK, Pack Number DYNJ42602C; 50) PACEMAKER PACK 0121271-LF, Pack Number DYNJ32897J; 51) PACEMAKER PACK CV-LF, Pack Number DYNJ39912B; 52) PACEMAKER PACK-LF, Pack Number DYNJ53112B; 53) PACEMAKER PACK-LF, Pack Number DYNJ51844B; 54) PACEMAKER PACK-LF, Pack Number DYNJ0854874R; 55) PEDI EP PACK, Pack Number DYNJ54750G; 56) PERMANENT PACING PACK-LF, Pack Number DYNJ22036F; 57) PK, OPEN HEART, Pack Number DYNJ44015B; 58) PK, OPEN HEART-CABG, Pack Number DYNJ45048C; 59) RR-ADULT PUMP PACK-LF, Pack Number DYNJ0394805N; 60) RRMC CAROTID PACK-2, Pack Number DYNJ33544L; 61) RR-PEDIATRIC PUMP PACK-LF, Pack Number DYNJ0394730P; 62) TAVR PACK, Pack Number DYNJ58386A; 63) THORACIC PACK, Pack Number DYNJ80309; 64) VASCULAR, Pack Number DYNJ45376G; 65) VASCULAR PACK, Pack Number DYNJ48288C; 66) VASCULAR PACK, Pack Number DYNJ54979; 67) VASCULAR PACK, Pack Number DYNJ64883C; 68) VASCULAR PACK, Pack Number DYNJ43945I; 69) VASCULAR PACK, Pack Number DYNJ43945I; 70) VASCULAR PACK, Pack Number DYNJ67426A; 71) VASCULAR PACK WRO-LF, Pack Number DYNJ41863C; 72) VASCULAR SUB, Pack Number DYNJ60681A; 73) VASCULAR SUB, Pack Number DYNJ60681A

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case), Lot Number 23DBG477A; 2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case), Lot Number 23LMD975A; 3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case), Lot Number 22GBV822Z; 4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case), Lot Number 22GMB113A; 5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case), Lot Number 21JMG551A; 6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case), Lot Number 23JBH403A; 7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case), Lot Number 21LBJ158A; 8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case), Lot Number 24AMF039A; 9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case), Lot Number 23LMF122A; 10) Pack Number DYNJ0810062AI: UDI/DI 10193489866049 (each) 40193489866040 (case), Lot Number 22CMB582A; 11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case), Lot Number 22JBD481Z; 12) Pack Number DYNJ59830A: UDI/DI 10193489570236 (each) 40193489570237 (case), Lot Number 21EMF434A; 13) Pack Number SYNJ10304B: UDI/DI 10193489786965 (each) 40193489786966 (case), Lot Number 21LBD584A; 14) Pack Number DYNJ53854A: UDI/DI 10193489631517 (each) 40193489631518 (case), Lot Number 21GMB561A; 15) Pack Number DYNJ30217G: UDI/DI 10193489922141 (each) 40193489922142 (case), Lot Number 23CBN679A; 16) Pack Number DYNJ56235: UDI/DI 10889942621552 (each) 40889942621553 (case), Lot Number 23EBD843A; 17) Pack Number DYNJ55482F: UDI/DI 10195327332273 (each) 40195327332274 (case), Lot Number 23BBS877A; 18) Pack Number DYNJ65916B: UDI/DI 10193489902044 (each) 40193489902045 (case), Lot Number 23JBT190A; 19) Pack Number DYNJ38059A: UDI/DI 10193489401110 (each) 40193489401111 (case), Lot Number 20LMF803A; 20) Pack Number DYNJ36931D: UDI/DI 10193489927559 (each) 40193489927550 (case), Lot Number 23BBS364Z; 21) Pack Number DYNJ60618C: UDI/DI 10193489475630 (each) 40193489475631 (case), Lot Number 22GMD148Z; 22) Pack Number CDS983376Q: UDI/DI 10195327379797 (each) 40195327379798 (case), Lot Number 23IBG370Z; 23) Pack Number DYNJ65226: UDI/DI 10193489253672 (each) 40193489253673 (case), Lot Number 20BDA909A; 24) Pack Number DYNJ59466A: UDI/DI 10193489562613 (each) 40193489562614 (case), Lot Number 21BBF996A; 25) Pack Number DYNJ900968I: UDI/DI 10193489453188 (each) 40193489453189 (case), Lot Number 22IBM300N; 26) Pack Number DYNJ54738C: UDI/DI 10193489778755 (each) 40193489778756 (case), Lot Number 21EBF317A; 27) Pack Number DYNJ63892A: UDI/DI 10195327176518 (each) 40195327176519 (case), Lot Number 23LME320A; 28) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22IBN057Z; 29) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22JBJ452Z; 30) Pack Number DYNJ905021J: UDI/DI 10195327281625 (each) 40195327281626 (case), Lot Number 23DBI088Z; 31) Pack Number DYNJ04478R: UDI/DI 10888277748835 (each) 40888277748836 (case), Lot Number 22GMA554A; 32) Pack Number DYNJ23533D: UDI/DI 10193489470659 (each) 40193489470650 (case), Lot Number 22GMC009A; 33) Pack Number CDS840171AB: UDI/DI 10195327167042 (each) 40195327167043 (case), Lot Number 22GMG011Z; 34) Pack Number DYNJ0382048N: UDI/DI 10195327537364 (each) 40195327537365 (case), Lot Number 23JBV598A; 35) Pack Number DYNJ45122C: UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 21EME856A; 36) Pack Number DYNJ55648: UDI/DI 10889942581900 (each) 40889942581901 (case), Lot Number 21LBN735A; 37) Pack Number DYNJ04381J: UDI/DI 10888277745155 (each) 40888277745156 (case), Lot Number 23GMB245A; 38) Pack Number DYNJ24300M: UDI/DI 10193489823608 (each) 40193489823609 (case), Lot Number 23FBL428A; 39) Pack Number DYNJ0369758N: UDI/DI 10193489501247 (each) 40193489501248 (case), Lot Number 22GBO541Z; 40) Pack Number DYNJ43038N: UDI/DI 10195327263911 (each) 40195327263912 (case), Lot Number 23EMD464A; 41) Pack Number DYNJ65641: UDI/DI 10193489282986 (each) 40193489282987 (case), Lot Number 21BBF660A; 42) Pack Number DYNJ67442B: UDI/DI 10195327133542 (each) 40195327133543 (case), Lot Number 23DBR515A; 43) Pack Number DYNJ59399I: UDI/DI 10195327442071 (each) 40195327442072 (case), Lot Number 23HMB191A; 44) Pack Number DYNJ0373237M: UDI/DI 10193489369014 (each) 40193489369015 (case), Lot Number 23LBU493Z; 45) Pack Number DYNJ66165: UDI/DI 10193489319729 (each) 40193489319720 (case), Lot Number 20DBP548A; 46) Pack Number DYNJ41134B: UDI/DI 10889942011643 (each) 40889942011644 (case), Lot Number 21BBI489A; 47) Pack Number DYNJ61260A: UDI/DI 10193489857481 (each) 40193489857482 (case), Lot Number 21HMF542A; 48) Pack Number DYNJ60635: UDI/DI 10193489518153 (each) 40193489518154 (case), Lot Number 21IMG997A; 49) Pack Number DYNJ42602C: UDI/DI 10195327019198 (each) 40195327019199 (case), Lot Number 23BBR329A; 50) Pack Number DYNJ32897J: UDI/DI 10193489648102 (each) 40193489648103 (case), Lot Number 20AKB914A; 51) Pack Number DYNJ39912B: UDI/DI 10889942705078 (each) 40889942705079 (case), Lot Number 21GMA579A; 52) Pack Number DYNJ53112B: UDI/DI 10193489650617 (each) 40193489650618 (case), Lot Number 21IMF023A; 53) Pack Number DYNJ51844B: UDI/DI 10889942615773 (each) 40889942615774 (case), Lot Number 21LME446A; 54) Pack Number DYNJ0854874R: UDI/DI 10195327094966 (each) 40195327094967 (case), Lot Number 22CMB704A; 55) Pack Number DYNJ54750G: UDI/DI 10195327021351 (each) 40195327021352 (case), Lot Number 22GBH035A; 56) Pack Number DYNJ22036F: UDI/DI 10889942528899 (each) 40889942528890 (case), Lot Number 20FBH674A; 57) Pack Number DYNJ44015B: UDI/DI 10193489215939 (each) 40193489215930 (case), Lot Number 23EMD927A; 58) Pack Number DYNJ45048C: UDI/DI 10193489808889 (each) 40193489808880 (case), Lot Number 21IMD394A; 59) Pack Number DYNJ0394805N: UDI/DI 10193489245240 (each) 40193489245241 (case), Lot Number 23LME396A; 60) Pack Number DYNJ33544L: UDI/DI 10195327279318 (each) 40195327279319 (case), Lot Number 23LMF755A; 61) Pack Number DYNJ0394730P: UDI/DI 10193489430943 (each) 40193489430944 (case), Lot Number 21LMG091A; 62) Pack Number DYNJ58386A: UDI/DI 10193489397468 (each) 40193489397469 (case), Lot Number 21VBB871A; 63) Pack Number DYNJ80309: UDI/DI 10195327023218 (each) 40195327023219 (case), Lot Number 23LMF645A; 64) Pack Number DYNJ45376G: UDI/DI 10195327209353 (each) 40195327209354 (case), Lot Number 23KMD075A; 65) Pack Number DYNJ48288C: UDI/DI 10888277745599 (each) 40888277745590 (case), Lot Number 21IMH225A; 66) Pack Number DYNJ54979: UDI/DI 10889942519910 (each) 40889942519911 (case), Lot Number 21LBL535Z; 67) Pack Number DYNJ64883C: UDI/DI 10193489369670 (each) 40193489369671 (case), Lot Number 23BBR373A; 68) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23GME703A; 69) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23HMC425A; 70) Pack Number DYNJ67426A: UDI/DI 10195327049317 (each) 40195327049318 (case), Lot Number 23HMC554A; 71) Pack Number DYNJ41863C: UDI/DI 10195327463632 (each) 40195327463633 (case), Lot Number 23HBW577A; 72) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 20EBI994A; 73) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 21BBI579A

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

18 other products · FDA event 96374

This product is part of a recall event; the main page for the event is Medline procedure kits labeled as: C Scope Disposable Kit recalled.

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025	CLASS II	Medline procedure kits labeled as: C Scope Disposable Kit recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: AV Fistula Pack-lf, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Laceration Tray recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Ablation Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: CV Neonatal Pack recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Bilateral Facet Tray, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Clovis Robotic-lf, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Delivery Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Arthroscopy Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Aop/Basic Eye Pack-lf recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: General Endoscopy Pack recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: A & A Knee Pack-lf, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: CT Biopsy Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Angio Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: L S GYN PACK, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: C Section, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Angio Drape Pack recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide

More recalls from Medline Industries LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	Medline Industries LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	Medline Industries LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	Medline Industries LP - Northfield	Labeling Errors	FL, IL

Other Pacemakers & Defibrillators recalls

All 494

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	DermaV Laser System recalled by Lutronic	Lutronic	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide