Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-0726-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Jan 1, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

Affected product

Check your device

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

Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6) CRANIOTOMY, SKU CDS982719Q; 7) CRANIOTOMY, SKU CDS982719R; 8) CRANIOTOMY, SKU CDS982719S; 9) CRANIOTOMY, SKU CDS982719T; 10) CRANIOTOMY, SKU CDS982719U; 11) CRANIOTOMY, SKU CDS982719V; 12) CRANIOTOMY, SKU CDS982719W; 13) CRANIOTOMY, SKU CDS984074I; 14) SPINE, SKU CDS984943I; 15) SPINE, SKU CDS984943J; 16) KIT NEURO CRANIOTOMY FOR TUMOR, SKU DYKMBNDL144; 17) KIT NEURO CRANIOTOMY FOR TUMOR, SKU DYKMBNDL144A; 18) CRANIOTOMY #IMF 56646-LF, SKU DYNJVB91001; 19) NEURO SPINE #IMF 56655-LF, SKU DYNJVB91004; 20) CRANIOTOMY HARPER PACK-LF, SKU DYNJ0162022G; 21) CRANIOTOMY PACK-LF, SKU DYNJ0530906AP; 22) CRANIOTOMY PACK-LF, SKU DYNJ0530906AQ; 23) LAMINECTOMY PACK-LF, SKU DYNJ17452R; 24) LAMINECTOMY PACK-LF, SKU DYNJ17452S; 25) CRANIOTOMY PACK-LF, SKU DYNJ17455J; 26) CRANIOTOMY PACK-LF, SKU DYNJ17455K; 27) DEPAUL CRANIOTOMY-LF, SKU DYNJ20018P; 28) SPINAL PROCEDURE SC, SKU DYNJ33402K; 29) LAMINECTOMY PACK SC, SKU DYNJ35328J; 30) CRANIOTOMY PACK 9128175-LF, SKU DYNJ35982J; 31) LAMINECTOMY PACK, SKU DYNJ37683J; 32) SPINAL RECONSTRUCTION PACK, SKU DYNJ37689G; 33) CRANIOTOMY PACK, SKU DYNJ37714G; 34) CRANIOTOMY PACK, SKU DYNJ38317G; 35) SPINE PACK-LF, SKU DYNJ38889I; 36) ORTHO SPINE, SKU DYNJ40221A; 37) ORTHO SPINE, SKU DYNJ40221B; 38) ORTHO SPINE, SKU DYNJ40221C; 39) ORTHO SPINE, SKU DYNJ40221D; 40) ORTHO SPINE, SKU DYNJ40221F; 41) CRANIOTOMY PK, SKU DYNJ40388B; 42) CRANIOTOMY-LF, SKU DYNJ43319F; 43) NEURO SPINE PACK 319728, SKU DYNJ44628D; 44) CRANI PACK-LF, SKU DYNJ44805L; 45) LAMINECTOMY PACK-LF, SKU DYNJ44815J; 46) NEURO SPINE PACK, SKU DYNJ45419D; 47) NEURO SPINE PACK, SKU DYNJ45419F; 48) SPINE PACK, SKU DYNJ46317F; 49) CRANI PACK, SKU DYNJ47605B; 50) SCRIPPS SW CRANIOTOMY PACK-LF, SKU DYNJ49653C; 51) PK) NEURO-CRANI, SKU DYNJ53453A; 52) ACDF PACK-LF, SKU DYNJ57136A; 53) PEDI CRANI MAJOR, SKU DYNJ59338C; 54) UMC CRANIOTOMY, SKU DYNJ60497A; 55) UMC CRANIOTOMY PK, SKU DYNJ60497B; 56) CMC NEURO PACK-LF, SKU DYNJ61079C; 57) CMC NEURO PACK-LF, SKU DYNJ61079D; 58) CRANIOTOMY PK, SKU DYNJ65934B; 59) METREX PACK-LF, SKU DYNJ66104A; 60) CRANIOTOMY PACK, SKU DYNJ66419; 61) CRANIOTOMY PACK, SKU DYNJ66419A; 62) CRANIOTOMY PACK RFID, SKU DYNJ66419B; 63) CRANIOTOMY PACK, SKU DYNJ67355A; 64) CRANIOTOMY PACK, SKU DYNJ67355B; 65) OSC LAMINECTOMY PACK, SKU DYNJ67395; 66) SPINE PACK, SKU DYNJ67505F; 67) SPINE PACK, SKU DYNJ67505G; 68) SPINE PACK, SKU DYNJ67652A; 69) NEURO CRANI PACK, SKU DYNJ69752; 70) SPINE PACK, SKU DYNJ69753; 71) SPINE PACK, SKU DYNJ80550A; 72) CRANI PACK, SKU DYNJ80554A; 73) SPINE PACK, SKU DYNJ82105; 74) LAMINECTOMY I-LF, SKU DYNJ83783; 75) ANTERIOR CERVICAL-LF, SKU DYNJ83785; 76) NEURO-CRANI PK-LF, SKU DYNJ85475; 77) CRANIOTOMY PACK, SKU DYNJ85527A; 78) CRANIOTOMY-LF, SKU DYNJ900718D; 79) WMC ANTERIOR CERVICAL-LF, SKU DYNJ902443D; 80) WMC LAMINECTOMY-LF, SKU DYNJ902468J; 81) WMC LAMINECTOMY-LF, SKU DYNJ902468K; 82) WMC LAMINECTOMY-LF, SKU DYNJ902468L; 83) WMC LAMINECTOMY-LF, SKU DYNJ902468M; 84) WMC CRANIOTOMY ADD ON-LF, SKU DYNJ902473L; 85) CRANIOTOMY, SKU DYNJ903224R; 86) CRANIOTOMY, SKU DYNJ903224S; 87) CRANIOTOMY, SKU DYNJ903224T; 88) CRANIOTOMY, SKU DYNJ903224V; 89) DAVIS LAMI, SKU DYNJ903452D; 90) ORTHO INS-SPINE BACK, SKU DYNJ904661D; 91) ORTHO INS-SPINE ACDF, SKU DYNJ904662D; 92) CCOC SPINE EHRLER, SKU DYNJ904681F; 93) KIT) SPINE LH, SKU DYNJ906448B; 94) CRANI, SKU DYNJ906469F; 95) SPINE, SKU DYNJ907030; 96) JVL - MODULE BURR HOLE - CRAN, SKU DYNJ907147A; 97) BGMC MICRODISK-SPINAL, SKU DYNJ907349B; 98) KIT PEDI CRANI LAMI, SKU DYNJ907372A; 99) KIT SPINAL INSTRUMENTATION, SKU DYNJ907376; 100) SPINE, SKU DYNJ907819A; 101) UMC CRANIOTOMY, SKU DYNJ907945; 102)

Lot / code information

UDI
CDS780045N, 10193489355406 (each), 40193489355407 (case)
Lot #
22JBI816 22JBI817
UDI
CDS780119U, 10193489371116 (each), 40193489371117 (case)
Lot #
22CBL018 21KBV760 21KBV761 21IBV579 21HBB379 21CBC828 21ABJ206 20JBX601 20HBC289
UDI
CDS780119V, 10195327114916 (each), 40195327114917 (case)
Lot #
22FBU189 22DBN874
UDI
CDS981753K, 10193489848946 (each), 40193489848947 (case)
Lot #
22DLA844
UDI
CDS981923X, 10195327434298 (each), 40195327434299 (case)
Lot #
23HBS882
Show 208 more code fields
UDI
CDS982719Q, 10193489634853 (each), 40193489634854 (case)
Lot #
20LBD073 20KBE409 20IBD650 20IBE719 20GBT868 20EBI282
UDI
CDS982719R, 10193489441031 (each), 40193489441032 (case)
Lot #
22CBD762 22CBD763 21LBG182 21IBU365 21DBU895 21CBA765 21BBN538
UDI
CDS982719S, 10195327148348 (each), 40195327148349 (case)
Lot #
22GBX154 22GBX157 22FBN679
UDI
CDS982719T, 10195327264161 (each), 40195327264162 (case)
Lot #
23CBO275 23BBG742 23ABP314 23ABQ860 22KBQ362 22JBR890
UDI
CDS982719U, 10195327359676 (each), 40195327359677 (case)
Lot #
23GBO912 23FBP663
UDI
CDS982719V, 10195327510831 (each), 40195327510832 (case)
Lot #
24BBI145 24BBC547 24ABB119 23LBN381 23KBP461
UDI
CDS982719W, 10195327645090 (each), 40195327645091 (case)
Lot #
24DBS813
UDI
CDS984074I, 10193489539240 (each), 40193489539241 (case)
Lot #
22FBW145 22FBW156 22EBN997 22CBP097 21LBX349 21KBB576 21HBG033 21HBG034 21EBO565 21EBK739 21CBV476 20KBI591 20IBR095
UDI
CDS984943I, 10193489805789 (each), 40193489805780 (case)
Lot #
21DBG136 21BBN662 20LBC741 20KBB644 20HBX447 20GBU951
UDI
CDS984943J, 10193489939828 (each), 40193489939829 (case)
Lot #
22IBT623 22EBN175 22EBM178 22ELA400 22OBM639 22BBY198 22BBQ629 21VBB560 21IBD939 21FBR368
UDI
DYKMBNDL144, 10193489478358 (each), 40193489478359 (case)
Lot #
22HLA742 22FLA327 22ELB110 22DLA896 22DLA727 22CLA771 22BLA947 21LLA651 21LLA431 21KLB158 21JLA461 21ILA240 21HLA660 21GLA871 21GLA640 21FLA052 21DLA534 21DLA128 21CLA448 21CLA295 21CLA414 21CBH443 21…Show all
22HLA742 22FLA327 22ELB110 22DLA896 22DLA727 22CLA771 22BLA947 21LLA651 21LLA431 21KLB158 21JLA461 21ILA240 21HLA660 21GLA871 21GLA640 21FLA052 21DLA534 21DLA128 21CLA448 21CLA295 21CLA414 21CBH443 21BLA414 21ABU821 21ABI784 20LLA543
UDI
DYKMBNDL144A, 10195327241032 (each), 40195327241033 (case)
Lot #
23GLA491 23FLA815 23DLA832 23BLA654 22LLA124 22JLB035 22ILA386
UDI
DYNJVB91001, 10193489801170 (each), 40193489801171 (case)
Lot #
23HLA649 23GLA935 23GLA081 23CLA457 23BLA516 22ILB117 22ILA306 21HLA380 21HLA223
UDI
DYNJVB91004, 10193489801163 (each), 40193489801164 (case)
Lot #
23KLA445 23ELB201 23ELA545 23DLA441 23DLA190 23CLB159 23CLA458 23CLA132 23BLA369 23BLA190 23BLA230 22LLA793 22LLA465 22KLA564 22KLA338 22JLA726 22ILB118 22HLA309 22FLA968 22DLA954 22CLA724 22CLA439 22…Show all
23KLA445 23ELB201 23ELA545 23DLA441 23DLA190 23CLB159 23CLA458 23CLA132 23BLA369 23BLA190 23BLA230 22LLA793 22LLA465 22KLA564 22KLA338 22JLA726 22ILB118 22HLA309 22FLA968 22DLA954 22CLA724 22CLA439 22ALA872 22ALA757 21LLA754 21KLB076 21LLA003 21GLA530 21ELA378 21DLA724 21DLA250 21CLA168 21BLA553
UDI
DYNJ0162022G, 10195327404598 (each), 40195327404599 (case)
Lot #
23HDA239
UDI
DYNJ0530906AP, 10195327629205 (each), 40195327629206 (case)
Lot #
24DBU441 24CBD922 24BBG480
UDI
DYNJ0530906AQ, 10198459023583 (each), 40198459023584 (case)
Lot #
24HBF736 24GBF740
UDI
DYNJ17452R, 10193489232745 (each), 40193489232746 (case)
Lot #
20HBU778 20DBV450
UDI
DYNJ17452S, 10193489448726 (each), 40193489448727 (case)
Lot #
24DBD546 24BBJ956 24ABI951 23LBD415 23JBS986 23IBN443 23EBS949 23CBV576 23BBD547 23ABE395 22IBQ636 22IBG316 22HBD921 22FBN962 22EBF435 22OBF142 22ABJ199 21KBR795 21KBR798 21HBL602 21FBC898 21FBC897 21…Show all
24DBD546 24BBJ956 24ABI951 23LBD415 23JBS986 23IBN443 23EBS949 23CBV576 23BBD547 23ABE395 22IBQ636 22IBG316 22HBD921 22FBN962 22EBF435 22OBF142 22ABJ199 21KBR795 21KBR798 21HBL602 21FBC898 21FBC897 21CBS933 21BBF488 21BBB399 20KBK827 20KBJ917
UDI
DYNJ17455J, 10193489776034 (each), 40193489776035 (case)
Lot #
20HBU443 20FBE933 20DBS073
UDI
DYNJ17455K, 10193489448733 (each), 40193489448734 (case)
Lot #
23FBR133 23CBH092 23CBE623 22LBN401 22FBK959 22NBF989 22BBK396 21IBK856 21BBA707 20LBS071
UDI
DYNJ20018P, 10193489614862 (each), 40193489614863 (case)
Lot #
22IBQ147 22HBX305
UDI
DYNJ33402K, 10889942620814 (each), 40889942620815 (case)
Lot #
22IBU396 22HBQ128
UDI
DYNJ35328J, 10193489777376 (each), 40193489777377 (case)
Lot #
22IBC437
UDI
DYNJ35982J, 10195327109936 (each), 40195327109937 (case)
Lot #
24DDB143 24CDC118 24CDB079 23KDA456 23IDC198 23GDA317 23ADA106 22LDB766 22GDA257 22GDA211 22DDB393
UDI
DYNJ37683J, 10193489884579 (each), 40193489884570 (case)
Lot #
22EMA087
UDI
DYNJ37689G, 10193489888409 (each), 40193489888400 (case)
Lot #
22FMA398
UDI
DYNJ37714G, 10193489884586 (each), 40193489884587 (case)
Lot #
23AMA818 22EMH802
UDI
DYNJ38317G, 10195327188337 (each), 40195327188338 (case)
Lot #
22IMA064
UDI
DYNJ38889I, 10193489433784 (each), 40193489433785 (case)
Lot #
22FMC983
UDI
DYNJ40221A, 10193489370706 (each), 40193489370707 (case)
Lot #
20LMF699 20IMD325
UDI
DYNJ40221B, 10193489468441 (each), 40193489468442 (case)
Lot #
22DMF929 22BMD063 21KMA783 21EMB370
UDI
DYNJ40221C, 10195327171094 (each), 40195327171095 (case)
Lot #
22IMI082 22FMI349
UDI
DYNJ40221D, 10195327281267 (each), 40195327281268 (case)
Lot #
23FMA091 23BMH798 23BMD590 23AMH384 22KMB544
UDI
DYNJ40221F, 10195327456931 (each), 40195327456932 (case)
Lot #
24HMG815 24FMJ976 24FMB924 24EMF243 24DMH392 24CMF885 24AMC568 23LMD920 23KMH840 23JMI665 23HMF284 23GMG445
UDI
DYNJ40388B, 10889942814510 (each), 40889942814511 (case)
Lot #
22CBY753
UDI
DYNJ43319F, 10193489379976 (each), 40193489379977 (case)
Lot #
23GBU044 22HBJ618 22FBX102
UDI
DYNJ44628D, 10195327336752 (each), 40195327336753 (case)
Lot #
23GBR938
UDI
DYNJ44805L, 10195327323516 (each), 40195327323517 (case)
Lot #
23GBD055
UDI
DYNJ44815J, 10195327323301 (each), 40195327323302 (case)
Lot #
23GBM522 23GBE280 23EBI826 23CBI837
UDI
DYNJ45419D, 10195327136116 (each), 40195327136117 (case)
Lot #
23HMF531 23GMA066 23FMH176 23EMH480 23EMC171 23DMH420 23CMF514 23BMC506 22LMI321 22IMF730 22IMF731 22EMH912
UDI
DYNJ45419F, 10195327625689 (each), 40195327625680 (case)
Lot #
24HMI873 24DMK493
UDI
DYNJ46317F, 10193489933154 (each), 40193489933155 (case)
Lot #
22GBM895
UDI
DYNJ47605B, 10193489730708 (each), 40193489730709 (case)
Lot #
22IBF896
UDI
DYNJ49653C, 10195327176730 (each), 40195327176731 (case)
Lot #
22HMA233
UDI
DYNJ53453A, 10193489227284 (each), 40193489227285 (case)
Lot #
23GBW468
UDI
DYNJ57136A, 10195327092160 (each), 40195327092161 (case)
Lot #
22EMF805
UDI
DYNJ59338C, 10195327021238 (each), 40195327021239 (case)
Lot #
23HLA933
UDI
DYNJ60497A, 10193489491494 (each), 40193489491495 (case)
Lot #
21EMD822 20LMF845 20LME508
UDI
DYNJ60497B, 10193489947649 (each), 40193489947640 (case)
Lot #
23CBJ364 22GBQ933 22FBK324 22EBB521 22DBP934 21IBU612 21IBJ071
UDI
DYNJ61079C, 10195327111335 (each), 40195327111336 (case)
Lot #
23FBA577 23EBF442 23CBC033 23BBB993 22LBP597 22LBN337 22HBJ629 22GBD922 22EBC676
UDI
DYNJ61079D, 10195327451561 (each), 40195327451562 (case)
Lot #
23GBS127
UDI
DYNJ65934B, 10193489918694 (each), 40193489918695 (case)
Lot #
22DBF055
UDI
DYNJ66104A, 10195327169480 (each), 40195327169481 (case)
Lot #
22FMI384
UDI
DYNJ66419, 10193489355468 (each), 40193489355469 (case)
Lot #
20KBH494
UDI
DYNJ66419A, 10195327105839 (each), 40195327105830 (case)
Lot #
23IBO363 23DBF776 23CBU127 23BBM754 22LBN481 22HBP355 22HBP708 22GBW915 22EBV485 22DBQ127
UDI
DYNJ66419B, 10195327670863 (each), 40195327670864 (case)
Lot #
24GBC523 24EBT820
UDI
DYNJ67355A, 10195327195441 (each), 40195327195442 (case)
Lot #
23FLA443 23ELA388 23CLA826 23BLA666 23ALA391 22ILB109 22HLB181 22HLA296
UDI
DYNJ67355B, 10195327456733 (each), 40195327456734 (case)
Lot #
23ILA135 23HLA122 23GLA964
UDI
DYNJ67395, 10193489895582 (each), 40193489895583 (case)
Lot #
22FMD453 22FMB381
UDI
DYNJ67505F, 10195327631734 (each), 40195327631735 (case)
Lot #
24CBE725
UDI
DYNJ67505G, 10195327670108 (each), 40195327670109 (case)
Lot #
24HBM784 24GBD561 24EBS299 24CBT451
UDI
DYNJ67652A, 10195327274542 (each), 40195327274543 (case)
Lot #
23HME139
UDI
DYNJ69752, 10193489977158 (each), 40193489977159 (case)
Lot #
22EBJ914
UDI
DYNJ69753, 10193489977233 (each), 40193489977234 (case)
Lot #
22EBV579
UDI
DYNJ80550A, 10195327064686 (each), 40195327064687 (case)
Lot #
22FBW070
UDI
DYNJ80554A, 10195327063313 (each), 40195327063314 (case)
Lot #
22GBC812
UDI
DYNJ82105, 10195327173074 (each), 40195327173075 (case)
Lot #
23HBV574
UDI
DYNJ83783, 10195327305918 (each), 40195327305919 (case)
Lot #
23CBP256
UDI
DYNJ83785, 10195327305932 (each), 40195327305933 (case)
Lot #
23CBP258
UDI
DYNJ85475, 10195327505905 (each), 40195327505906 (case)
Lot #
24DMK076 23KMJ165
UDI
DYNJ85527A, 10195327565176 (each), 40195327565177 (case)
Lot #
23LBM088
UDI
DYNJ900718D, 10195327686383 (each), 40195327686384 (case)
Lot #
24HLA805 24GLB147 24GLA248
UDI
DYNJ902443D, 10195327261276 (each), 40195327261277 (case)
Lot #
24HBF620 24DBG611 23JBP842 23IBW095 23GBK736 23CBO765 23BBD677
UDI
DYNJ902468J, 10195327261337 (each), 40195327261338 (case)
Lot #
23ABB960 22JBY742
UDI
DYNJ902468K, 10195327323462 (each), 40195327323463 (case)
Lot #
23BBG726
UDI
DYNJ902468L, 10195327372293 (each), 40195327372294 (case)
Lot #
23IBO118 23HBK165 23FBO857 23DBN202
UDI
DYNJ902468M, 10198459028151 (each), 40198459028152 (case)
Lot #
24IBF034 24GBX534 24GBK426
UDI
DYNJ902473L, 10195327261436 (each), 40195327261437 (case)
Lot #
24ILA785 24ILA873 24ILA207 24HLA861 24HLA234 24GLA863 24GLA393 24ELA488 24DLA998 24CLA160 24ALA895 23LLA737 23KLB004 23KLA717 23KLA364 23ILA370 23GLA828 23GLA226 23FLA906 23DLA438 23CLA765 22LLA076
UDI
DYNJ903224R, 10195327254261 (each), 40195327254262 (case)
Lot #
22KDB985
UDI
DYNJ903224S, 10195327328702 (each), 40195327328703 (case)
Lot #
23IDA634 23BDB731 23ADC091
UDI
DYNJ903224T, 10195327491086 (each), 40195327491087 (case)
Lot #
24FDA232 24CDC017 24BDB603 23LDB727 23JDC541 23JDA679 23IDC174
UDI
DYNJ903224V, 10198459060700 (each), 40198459060701 (case)
Lot #
24IDA272
UDI
DYNJ903452D, 10193489667820 (each), 40193489667821 (case)
Lot #
22IBQ075
UDI
DYNJ904661D, 10193489263190 (each), 40193489263191 (case)
Lot #
23KBX356 23JBX848 23IBL881 23IBM306 23GBU556 23FBV382 23CBG855 23ABU277 22LBF701 22JBY022 22HBS591 22FBN765 22FBN766 22EBV206 22OBG856 22OBB277 22OBB280 21LBQ921 21IBU503 21GBC720 21FBF890 21DBU712 21…Show all
23KBX356 23JBX848 23IBL881 23IBM306 23GBU556 23FBV382 23CBG855 23ABU277 22LBF701 22JBY022 22HBS591 22FBN765 22FBN766 22EBV206 22OBG856 22OBB277 22OBB280 21LBQ921 21IBU503 21GBC720 21FBF890 21DBU712 21CBE922 20EBT013
UDI
DYNJ904662D, 10193489263206 (each), 40193489263207 (case)
Lot #
23GBI899 23GBB212 23EBI632 23CBW838 23BBN983 23ABM490 22LBL126 22KBK688 22HBI868 22FBR270 22FBD458 22CLA847 22OBG841 22OBC072 22CLA235 21LBQ894 21JBM726 21GBS644 21FBJ147 21CBF257 21ABC418 20LBP879 20…Show all
23GBI899 23GBB212 23EBI632 23CBW838 23BBN983 23ABM490 22LBL126 22KBK688 22HBI868 22FBR270 22FBD458 22CLA847 22OBG841 22OBC072 22CLA235 21LBQ894 21JBM726 21GBS644 21FBJ147 21CBF257 21ABC418 20LBP879 20EBS185 20DBT259
UDI
DYNJ904681F, 10193489803815 (each), 40193489803816 (case)
Lot #
21EBC584 21BBB752 20KBL927 20GBC237 20FBC077
UDI
DYNJ906448B, 10193489902921 (each), 40193489902922 (case)
Lot #
22EBD157 22EBC254 22OBA537 22ABY321 21LBV221 21KBC470
UDI
DYNJ906469F, 10195327210939 (each), 40195327210930 (case)
Lot #
24HDA679 24FDA986 24BDB183 24BDB024 24ADA127 23IDC208 22KDA497 22JDB698 22IDB052 22HDC339
UDI
DYNJ907030, 10193489325157 (each), 40193489325158 (case)
Lot #
23BBU288 23ABT337 23ABS755 23ABN657 22JBB240 22EBI159 22EBG643 22EBH392 22DBE448 22OBI458 21LBU018 21LBU024 21EBO764 20JBO764 20JBL133 20DBO898
UDI
DYNJ907147A, 10195327130770 (each), 40195327130771 (case)
Lot #
22JBU269 22HBQ420 22GBR824
UDI
DYNJ907349B, 10195327449568 (each), 40195327449569 (case)
Lot #
23IBC888
UDI
DYNJ907372A, 10195327060411 (each), 40195327060412 (case)
Lot #
23JLA329
UDI
DYNJ907376, 10193489889741 (each), 40193489889742 (case)
Lot #
22GMB505
UDI
DYNJ907819A, 10195327401054 (each), 40195327401055 (case)
Lot #
23IBA532 23IBA146 23GBU799
UDI
DYNJ907945, 10193489947762 (each), 40193489947763 (case)
Lot #
23DBK646 23DBC953 22IBF953 22IBE829 22FBX834 22FBX835 22EBP537 22EBL544 22BBH770 21IBV572
UDI
DYNJ908144, 10193489982190 (each), 40193489982191 (case)
Lot #
21IBK042
UDI
DYNJ908313, 10195327031459 (each), 40195327031450 (case)
Lot #
23FBI071 23EBJ976 23ABP542 23ABE843 22LBB598 22JBT238 22JBA956 22EBQ482 22EBP641 21LBE373
UDI
DYNJ908313A, 10195327436957 (each), 40195327436958 (case)
Lot #
23IBT847 23HBT388 23GBO771
UDI
DYNJ908699, 10195327159382 (each), 40195327159383 (case)
Lot #
22HBO460
UDI
DYNJ908964, 10195327225780 (each), 40195327225781 (case)
Lot #
23FBC228 22KBD892
UDI
DYNJ908964A, 10195327525811 (each), 40195327525812 (case)
Lot #
24DBI341 24CBD458
UDI
DYNJ909063A, 10195327460549 (each), 40195327460540 (case)
Lot #
23HLB085
UDI
DYNJ909364, 10195327319090 (each), 40195327319091 (case)
Lot #
24CMC543 24BME891 24BME394 23LMF488 23LMB263 23IMH228 23IMD363 23HME707 23HME026 23CMI093

What the firm is doing

An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-209-FGX1 Recall Code: Recall Code 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

US Nationwide. Canada.

Class IIWhat this means

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

Sources & references

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

Taylor Coteus
Legal News Analyst

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

More Class II recalls