FDAClass IIDecember 11, 2024

MEDLINE convenience kits labeled as: 1) ZALE HEAD recall

MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK…

Why was MEDLINE convenience kits labeled as: 1) ZALE HEAD recalled?

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) REF CDS983184I, UDI/DI 10195327178352 (each) 40195327178353 (case), Lot Numbers: 22LBB795, 23FBJ754, 23BBH106, 23CBT619, 23HBY087, 23HBP974, 23KBI669, 23LBD939, 23KBM394; 2) REF CDS983466L, UDI/DI 10195327497217 (each) 40195327497218 (case), Lot Numbers: 23JDB850, 23IDB539, 23KDB596, 24DDB278, 24DDA871, 24BDA878, 24ADA819, 24CDB315; 3) REF CDS983486K, UDI/DI 10195327497200 (each) 40195327497201 (case), Lot Numbers: 23JDA349, 24CDA873, 24ADA731, 24ADB821; 4) REF CDS984259N, UDI/DI 10193489862232 (each) 40193489862233 (case), Lot Numbers: 22KBJ788, 22JBH993, 22JBH284, 22LBB413; 5) REF CDS984259O, UDI/DI 10195327297817 (each) 40195327297818 (case), Lot Numbers: 23ABM783, 23ABK571; 6) REF CDS984282L, UDI/DI 10195327438920 (each) 40195327438921 (case), Lot Numbers: 23LMA461; 7) REF CDS984895I, UDI/DI 10193489983814 (each) 40193489983815 (case), Lot Numbers: 22FBL382, 22KBD792, 23DBM334, 23ABM451, 23FBK273; 8) REF CDS984895J, UDI/DI 10195327469092 (each) 40195327469093 (case), Lot Numbers: 23KBH104, 23KBH045; 9) REF CDS984895K, UDI/DI 10195327620875 (each) 40195327620876 (case), Lot Numbers: 24BBQ203, 24CBM385; 10) REF DYNJ0101206D, UDI/DI 10195327028855 (each) 40195327028856 (case), Lot Numbers: 22EMG943, 22GMB620; 11) REF DYNJ0101206F, UDI/DI 10195327269470 (each) 40195327269471 (case), Lot Numbers: 22KMB120, 22KMB121, 23EMB091, 23DMB727, 23BMD165, 23FMD066, 23GMH580, 23JMA281, 23KBV062, 24ABN126, 24DBT379, 24DBD204; 12) REF DYNJ0101314D, UDI/DI 10195327286453 (each) 40195327286454 (case), Lot Numbers: 23HDA133, 23FDA245; 13) REF DYNJ0101397M, UDI/DI 10195327295813 (each) 40195327295814 (case), Lot Numbers: 22LBL740; 14) REF DYNJ0101397N, UDI/DI 10195327332952 (each) 40195327332953 (case), Lot Numbers: 23ABU509, 23FBJ127, 23CBT405, 23IBK582; 15) REF DYNJ0131777I, UDI/DI 10195327124755 (each) 40195327124756 (case), Lot Numbers: 22FMH017; 16) REF DYNJ0131777J, UDI/DI 10195327216627 (each) 40195327216628 (case), Lot Numbers: 22GMH364; 17) REF DYNJ0131777K, UDI/DI 10195327248031 (each) 40195327248032 (case), Lot Numbers: 23BMC153, 22JMF782, 22LMB801, 23CME007; 18) REF DYNJ0131777L, UDI/DI 10195327416065 (each) 40195327416066 (case), Lot Numbers: 23IMA466, 23GMI881, 23IMG022, 23LMA388, 23KMB800, 23FMI119, 24AMI064, 24CMA472; 19) REF DYNJ0160700F, UDI/DI 10195327304294 (each) 40195327304295 (case), Lot Numbers: 22LDC085, 23DDB405; 20) REF DYNJ0161710G, UDI/DI 10195327304300 (each) 40195327304301 (case), Lot Numbers: 23BDA563, 23ADB489; 21) REF DYNJ0161710I, UDI/DI 10195327375003 (each) 40195327375004 (case), Lot Numbers: 23DDB344, 23DDA346; 22) REF DYNJ02462L, UDI/DI 10195327269975 (each) 40195327269976 (case), Lot Numbers: 23HMB171; 23) REF DYNJ02463J, UDI/DI 10195327291112 (each) 40195327291113 (case), Lot Numbers: 23IMI445, 23JMJ897; 24) REF DYNJ0387711F, UDI/DI 10198459005893 (each) 40198459005894 (case), Lot Numbers: 24FMI719; 25) REF DYNJ0429404O, UDI/DI 10195327050092 (each) 40195327050093 (case), Lot Numbers: 22EMH911, 22HMD262, 22KMD325, 23CMH759, 23CMC034; 26) REF DYNJ0451506P, UDI/DI 10195327046033 (each) 40195327046034 (case), Lot Numbers: 22FBD904, 22IBG229, 22KBJ001, 22KBF361, 22FBJ383, 23CBA965, 23CBC262, 23HBP907, 23FBJ832, 23KBJ579, 23IBW132; 27) REF DYNJ0774664K, UDI/DI 10195327045999 (each) 40195327045990 (case), Lot Numbers: 23FBV288, 23FBD634, 23IBP555; 28) REF DYNJ0826705N, UDI/DI 10193489265682 (each) 40193489265683 (case), Lot Numbers: 22GMA868, 23EMI243, 23KMJ016; 29) REF DYNJ0843898I, UDI/DI 10195327288693 (each) 40195327288694 (case), Lot Numbers: 23DDB257, 23ADB839, 23GDA828, 23IDC126; 30) REF DYNJ21948S, UDI/DI 10195327104726 (each) 40195327104727 (case), Lot Numbers: 22JBB180, 22JBC021; 31) REF DYNJ27320V, UDI/DI 10195327104719 (each) 40195327104710 (case), Lot Numbers: 22DBE423, 22DBS049, 22JBH705, 22DBB586, 23EBE794, 22LBQ654, 22DBS054, 23CBL338, 23FBO863; 32) REF DYNJ33585F, UDI/DI 10195327469528 (each) 40195327469529 (case), Lot Numbers: 23HDB160, 23JDA407; 33) REF DYNJ37531G, UDI/DI 10195327497224 (each) 40195327497225 (case), Lot Numbers: 23IDC199, 24DDA059; 34) REF DYNJ43111G, UDI/DI 10195327007614 (each) 40195327007615 (case), Lot Numbers: 22EBK964, 22DBM378, 23ABD640, 22JBK014, 23FBR570, 23GBW466, 23JBS323, 23KBV859, 24BBA668, 24CBH236; 35) REF DYNJ43776G, UDI/DI 10193489989717 (each) 40193489989718 (case), Lot Numbers: 22GBK302, 22JBD640, 23BBA747, 23GBN842, 22JBG530, 23GBS093, 23JBT523, 24ABR379, 24CBD054, 24EBE400; 36) REF DYNJ44170G, UDI/DI 10195327413040 (each) 40195327413041 (case), Lot Numbers: 23KBF904; 37) REF DYNJ44982J, UDI/DI 10195327381080 (each) 40195327381081 (case), Lot Numbers: 23HBH626, 23FBE306; 38) REF DYNJ45576B, UDI/DI 10195327059200 (each) 40195327059201 (case), Lot Numbers: 23DBJ589, 23DBB974, 22JBD150, 22IBS180, 23GBP473, 23IBI793, 23JBS988, 23GBA243, 23FBF257; 39) REF DYNJ48370C, UDI/DI 10195327491635 (each) 40195327491636 (case), Lot Numbers: 23IBK589, 23JBH535; 40) REF DYNJ52419J, UDI/DI 10195327222703 (each) 40195327222704 (case), Lot Numbers: 22HDB178; 41) REF DYNJ52419K, UDI/DI 10195327339265 (each) 40195327339266 (case), Lot Numbers: 23DDB020, 23BDC171, 23HDB272, 23FDC083; 42) REF DYNJ52426J, UDI/DI 10195327339333 (each) 40195327339334 (case), Lot Numbers: 23DDB127, 23HDB256, 23FDA419; 43) REF DYNJ52758G, UDI/DI 10195327409685 (each) 40195327409686 (case), Lot Numbers: 23HBE646, 23EBU553, 23JBE363; 44) REF DYNJ53648B, UDI/DI 10195327012083 (each) 40195327012084 (case), Lot Numbers: 22GBH903, 23GBQ991, 24DBT986, 23ABJ120, 23EBB251, 23GBS479; 45) REF DYNJ56995C, UDI/DI 10195327103415 (each) 40195327103416 (case), Lot Numbers: 22EBQ045, 22GBM277; 46) REF DYNJ60922F, UDI/DI 10195327470265 (each) 40195327470266 (case), Lot Numbers: 23IBK275; 47) REF DYNJ61309B, UDI/DI 10195327155735 (each) 40195327155736 (case), Lot Numbers: 22EMC922, 22LMD294, 23JBV869; 48) REF DYNJ62032B, UDI/DI 10195327058289 (each) 40195327058280 (case), Lot Numbers: 22FBP870, 22KBG692, 23BBD433, 23EBR621, 23IBK599, 23GBM365; 49) REF DYNJ62649A, UDI/DI 10195327109912 (each) 40195327109913 (case), Lot Numbers: 22GDA925, 22EDB879, 22KDB262, 22JDA165, 22KDB900; 50) REF DYNJ63315B, UDI/DI 10193489958102 (each) 40193489958103 (case), Lot Numbers: 22FBY596, 22FBR138; 51) REF DYNJ63332F, UDI/DI 10195327270773 (each) 40195327270774 (case), Lot Numbers: 23HMF316; 52) REF DYNJ63333B, UDI/DI 10193489986877 (each) 40193489986878 (case), Lot Numbers: 22EBV290, 22DBV017; 53) REF DYNJ63333C, UDI/DI 10195327270018 (each) 40195327270019 (case), Lot Numbers: 23GMC984, 23AMI108, 23FMG683, 23IMG360; 54) REF DYNJ63334C, UDI/DI 10195327041243 (each) 40195327041244 (case), Lot Numbers: 22DBN552; 55) REF DYNJ63334D, UDI/DI 10195327275679 (each) 40195327275670 (case), Lot Numbers: 22LME564, 23BMB162, 23HMF139, 23JMG131; 56) REF DYNJ63336B, UDI/DI 10193489943740 (each) 40193489943741 (case), Lot Numbers: 22FBR970; 57) REF DYNJ63336C, UDI/DI 10195327273422 (each) 40195327273423 (case), Lot Numbers: 23AMA553, 23IMG718, 23HMF616, 23KMF634, 23JMA204, 23IMD286; 58) REF DYNJ63625C, UDI/DI 10195327350390 (each) 40195327350391 (case), Lot Numbers: 23CBT772, 23JBA948, 23EBU585, 23IBB697, 23JBO841; 59) REF DYNJ63890A, UDI/DI 10195327221843 (each) 40195327221844 (case), Lot Numbers: 22JDC115, 23GDB230, 23BDA782, 23JDB416, 23KDB075, 23CDC581, 23IDA389, 24DDB748; 60) REF DYNJ64235B, UDI/DI 10193489382662 (each) 40193489382663 (case), Lot Numbers: 22GMI068, 23CMD690; 61) REF DYNJ65487B, UDI/DI 10195327303662 (each) 40195327303663 (case), Lot Numbers: 23ABN443, 23CBM523, 23IBM894; 62) REF DYNJ67401B, UDI/DI 10195327353001 (each) 40195327353002 (case), Lot Numbers: 23CMG483, 23DMD152, 23KMH872; 63) REF DYNJ67754B, UDI/DI 10195327227982 (each) 40195327227983 (case), Lot Numbers: 22HBR985, 22HBT613, 22JBX075, 22LBJ260, 23BBS826, 23DBC526; 64) REF DYNJ67985B, UDI/DI 10195327022679 (each) 40195327022670 (case), Lot Numbers: 22EMG226; 65) REF DYNJ67985C, UDI/DI 10195327270407 (each) 40195327270408 (case), Lot Numbers: 23KMJ096; 66) REF DYNJ68211B, UDI/DI 10195327352493 (each) 40195327352494 (case), Lot Numbers: 23FMF614; 67) REF DYNJ69587B, UDI/DI 10195327372354 (each) 40195327372355 (case), Lot Numbers: 23HMC907, 24DMA249; 68) REF DYNJ82172, UDI/DI 10195327182601 (each) 40195327182602 (case), Lot Numbers: 23FDA365; 69) REF DYNJ82175, UDI/DI 10195327182618 (each) 40195327182619 (case), Lot Numbers: 23HDB289; 70) REF DYNJ82175B, UDI/DI 10195327534929 (each) 40195327534920 (case), Lot Numbers: 23JMG205; 71) REF DYNJ82177, UDI/DI 10195327182656 (each) 40195327182657 (case), Lot Numbers: 23FDC242; 72) REF DYNJ82177B, UDI/DI 10195327534936 (each) 40195327534937 (case), Lot Numbers: 23KMC523; 73) REF DYNJ82194, UDI/DI 10195327183486 (each) 40195327183487 (case), Lot Numbers: 23FDC244; 74) REF DYNJ82285, UDI/DI 10195327179045 (each) 40195327179046 (case), Lot Numbers: 23IMC659; 75) REF DYNJ82654A, UDI/DI 10195327489649 (each) 40195327489640 (case), Lot Numbers: 23KBF180, 23IBU511, 23HBT084; 76) REF DYNJ82654B, UDI/DI 10195327557690 (each) 40195327557691 (case), Lot Numbers: 23LBJ944, 24ABW630, 24DBT628, 24CBV286; 77) REF DYNJ82656C, UDI/DI 10195327489656 (each) 40195327489657 (case), Lot Numbers: 23IBR904; 78) REF DYNJ82657A, UDI/DI 10195327489663 (each) 40195327489664 (case), Lot Numbers: 23IBS673; 79) REF DYNJ82657B, UDI/DI 10195327557782 (each) 40195327557783 (case), Lot Numbers: 24ABK113, 24BBP749, 24DBF082, 24DBQ952; 80) REF DYNJ901073G, UDI/DI 10193489944600 (each) 40193489944601 (case), Lot Numbers: 22EMH483, 22IMF369, 22HMI055, 22HMC726, 22GMI088, 22GME976, 22KMA663, 22IMF609, 22GMB443; 81) REF DYNJ901073I, UDI/DI 10195327232504 (each) 40195327232505 (case), Lot Numbers: 22KMC464, 23BMB966, 23AMF537, 23AME484; 82) REF DYNJ901801K, UDI/DI 10195327495534 (each) 40195327495535 (case), Lot Numbers: 24CDA462, 23JDC094, 24ADA394; 83) REF DYNJ902116I, UDI/DI 10195327497422 (each) 40195327497423 (case), Lot Numbers: 23JDB483, 23KDB475, 24ADA959, 24CDB867; 84) REF DYNJ902126I, UDI/DI 10195327497231 (each) 40195327497232 (case), Lot Numbers: 23LDA136, 24BDB428, 24ADA164; 85) REF DYNJ902258J, UDI/DI 10195327497477 (each) 40195327497478 (case), Lot Numbers: 24ADA255, 24ADA820, 24BDB764; 86) REF DYNJ902508I, UDI/DI 10195327336677 (each) 40195327336678 (case), Lot Numbers: 23EBR103; 87) REF DYNJ903810C, UDI/DI 10193489274134 (each) 40193489274135 (case), Lot Numbers: 22JBR487, 23IBG239, 23HBO191, 23KBC866, 23EBP263, 24ABA510, 24BBV513, 24BBE242; 88) REF DYNJ904491J, UDI/DI 10195327157517 (each) 40195327157518 (case), Lot Numbers: 22EBU208; 89) REF DYNJ904491K, UDI/DI 10195327186333 (each) 40195327186334 (case), Lot Numbers: 23ABV356; 90) REF DYNJ904558F, UDI/DI 10195327497378 (each) 40195327497379 (case), Lot Numbers: 24DDC043; 91) REF DYNJ906052B, UDI/DI 10195327010164 (each) 40195327010165 (case), Lot Numbers: 22IBA880, 23CBG753, 23BBL154, 23DBF038; 92) REF DYNJ906655F, UDI/DI 10193489993998 (each) 40193489993999 (case), Lot Numbers: 22JDC012, 22IDB318, 22GDB705, 22LDA295; 93) REF DYNJ906655G, UDI/DI 10195327301835 (each) 40195327301836 (case), Lot Numbers: 23GDB026, 23HDC613, 23EDB087, 23FDA004; 94) REF DYNJ906901A, UDI/DI 10195327303358 (each) 40195327303359 (case), Lot Numbers: 23ABE779, 23FBP600, 23HBS841; 95) REF DYNJ906948B, UDI/DI 10195327380991 (each) 40195327380992 (case), Lot Numbers: 23EBD951, 23LBE795, 23HBI581, 23EBN930, 23HBY101, 23GBS824; 96) REF DYNJ906948C, UDI/DI 10195327567156 (each) 40195327567157 (case), Lot Numbers: 24ABQ831, 24CBD478, 24DBD740, 24DBN334; 97) REF DYNJ907206F, UDI/DI 10195327600907 (each) 40195327600908 (case), Lot Numbers: 24BBL775, 24DBM144; 98) REF DYNJ907393C, UDI/DI 10195327359133 (each) 40195327359134 (case), Lot Numbers: 23EMD891; 99) REF DYNJ907393D, UDI/DI 10195327462345 (each) 40195327462346 (case), Lot Numbers: 23IMG307; 100) REF DYNJ907411A, UDI/DI 10195327335748 (each) 40195327335749 (case), Lot Numbers: 23GMC938; 101) REF DYNJ907577, UDI/DI 10193489437713 (each) 40193489437714 (case), Lot Numbers: 22GBH331, 22HBS399, 23IBO496, 23CBW088; 102) REF DYNJVB91072, UDI/DI 10193489801156 (each) 40193489801157 (case), Lot Numbers: 22ILA262, 22HLA486

Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
24754 units
Distribution
US Nationwide distribution.
Recall date
December 11, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls