Class II FDA device recall · Z-0629-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T A PACK RFID, REF DYNJ0101397N; 15) THYROID PACK-LF, REF DYNJ0131777I; 16) THYROID PACK-LF, REF DYNJ0131777J; 17) THYROID PACK-LF, REF DYNJ0131777K; 18) THYROID PACK-LF, REF DYNJ0131777L; 19) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 20) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710G; 21) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 22) T&A PACK, REF DYNJ02462L; 23) ENT/HEAD & NECK PACK, REF DYNJ02463J; 24) ENT BASIC PACK-LF, REF DYNJ0387711F; 25) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 26) MAJOR ENT PACK-LF, REF DYNJ0451506P; 27) EAR PACK-LF, REF DYNJ0774664K; 28) MAJOR HEAD/NECK PACK-LF, REF DYNJ0826705N; 29) TRANSPHENOIDAL PACK-LF, REF DYNJ0843898I; 30) MINOR HEAD & NECK #40-RF, REF DYNJ21948S; 31) NASALPLASTY #61-RF, REF DYNJ27320V; 32) DB ENT CSTM PACK-LF, REF DYNJ33585F; 33) ENT RECONSTRUCTION PK, REF DYNJ37531G; 34) BEC MOHS PACK, REF DYNJ43111G; 35) SVMMC HEAD AND NECK PACK, REF DYNJ43776G; 36) TONSIL PACK, REF DYNJ44170G; 37) T AND A PACK, REF DYNJ44982J; 38) MAJOR ENT PACK, REF DYNJ45576B; 39) MAJOR ENT PACK, REF DYNJ48370C; 40) HEAD & NECK PACK, REF DYNJ52419J; 41) HEAD & NECK PK-RFID, REF DYNJ52419K; 42) BL THYROID PK RFID- LF, REF DYNJ52426J; 43) HEAD & NECK PACK, REF DYNJ52758G; 44) THYROID PACK, REF DYNJ53648B; 45) SMH HEAD & NECK PACK, REF DYNJ56995C; 46) CHRISTUS SR HEAD AND NECK PACK, REF DYNJ60922F; 47) HEAD&NECK PACK, REF DYNJ61309B; 48) MHPB HEAD AND NECK PACK, REF DYNJ62032B; 49) SMH THYROID PACK, REF DYNJ62649A; 50) TRANSSPHENOIDAL, REF DYNJ63315B; 51) TYMPANOPLASTY, REF DYNJ63332F; 52) AFCH TONSIL, REF DYNJ63333B; 53) AFCH TONSIL, REF DYNJ63333C; 54) TAC THYROIDECTOMY PACK, REF DYNJ63334C; 55) TAC THYROIDECTOMY PACK, REF DYNJ63334D; 56) HEAD NECK PACK IP, REF DYNJ63336B; 57) HEAD NECK PACK IP, REF DYNJ63336C; 58) THYROID TRAY FFX, REF DYNJ63625C; 59) ENT DRAPE PACK, REF DYNJ63890A; 60) HEAD AND NECK, REF DYNJ64235B; 61) PACK,HEAD AND NECK, REF DYNJ65487B; 62) PEDI ENT PACK, REF DYNJ67401B; 63) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 64) OSC HEAD AND NECK PACK, REF DYNJ67985B; 65) OSC HEAD AND NECK PACK, REF DYNJ67985C; 66) ENT HEAD NECK PACK, REF DYNJ68211B; 67) ENT BASIC PACK-LF, REF DYNJ69587B; 68) EAR PACK, REF DYNJ82172; 69) ENT MINOR PACK, REF DYNJ82175; 70) ENT MINOR PACK, REF DYNJ82175B; 71) FACIAL PACK, REF DYNJ82177; 72) FACIAL PACK, REF DYNJ82177B; 73) MEDIASTINOSCOPY PACK, REF DYNJ82194; 74) EAR ENT PACK, REF DYNJ82285; 75) HEAD AND NECK PACK, REF DYNJ82654A; 76) HEAD AND NECK PACK, REF DYNJ82654B; 77) GENERAL EAR PACK, REF DYNJ82656C; 78) T AND A PACK, REF DYNJ82657A; 79) T AND A PACK, REF DYNJ82657B; 80) ORAL NASAL, REF DYNJ901073G; 81) ORAL NASAL, REF DYNJ901073I; 82) EAR-LF, REF DYNJ901801K; 83) T&A, REF DYNJ902116I; 84) ENT RESECTION, REF DYNJ902126I; 85) OMFS, REF DYNJ902258J; 86) THYROID, REF DYNJ902508I; 87) HEAD AND NECK, REF DYNJ903810C; 88) TRIPOINT HEAD AND NECK, REF DYNJ904491J; 89) TRIPOINT HEAD AND NECK, REF DYNJ904491K; 90) PLASTIC CRANIOPLASTY-LF, REF DYNJ904558F; 91) CW T&A SINUS, REF DYNJ906052B; 92) HEAD&NECK, REF DYNJ906655F; 93) HEAD&NECK, REF DYNJ906655G; 94) PACK,COCHLEAR IMPLANT, REF DYNJ906901A; 95) HEAD&NECK, REF DYNJ906948B; 96) HEAD&NECK, REF DYNJ906948C; 97) WMC COCHLEAR IMPLANT ADD ON, REF DYNJ907206F; 98) PLASTIC ENT, REF DYNJ907393C; 99) PLASTIC ENT, REF DYNJ907393D; 100) PLASTIC ENT - NTSC, REF DYNJ907411A; 101) ENT-LF, REF DYNJ907577; 102) MINOR ENT # 56653-LF, REF DYNJVB91072

Why it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-0629-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2024-10-09

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0629-2025 · Source: openFDA enforcement.