| | Class 2 Device Recall Medline Convenience Kits |  |
| Date Initiated by Firm | January 07, 2026 |
|---|
| Date Posted | May 07, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2107-2026 |
|---|
| Recall Event ID |
98642 |
| Product Classification |
Neurological tray - Product Code OJG
|
| Product | Medline Convenience Kits:
1) NEURO SHUNT- CODMAN, Model Number: CDS860018G;
2) NEURO SHUNT- CODMAN, Model Number: CDS860018I;
3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138;
4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142;
5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B;
6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145;
7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B;
8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5;
9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B;
10) NEURO PACK-LF, Model Number: DYNJ0305809O;
11) NEURO PACK-LF, Model Number: DYNJ0305809P;
12) NEURO PACK-LF, Model Number: DYNJ0408776Y;
13) NEURO PACK-LF, Model Number: DYNJ04596K;
14) NEURO/LAMINECTOMY BASIN PK-LF, Model Number: DYNJ0781823K;
15) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L;
16) NEURO PACK, Model Number: DYNJ49098I;
17) NEURO PACK, Model Number: DYNJ53089B;
18) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799;
19) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A;
20) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C;
21) NEURO PACK, Model Number: DYNJ60792B;
22) NEURO PACK, Model Number: DYNJ60792C;
23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C;
24) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D;
25) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157F;
26) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D;
27) NEURO PACK, Model Number: DYNJ61740D;
28) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998;
29) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A;
30) DISCECTOMY PACK, Model Number: DYNJ67835;
31) FSC NEURO PACK, Model Number: DYNJ80442B;
32) WWD NEURO PACK, Model Number: DYNJ80849B;
33) WWD NEURO PACK, Model Number: DYNJ80849C;
34) WWD NEURO PACK, Model Number: DYNJ80849D;
35) WWD NEURO PACK, Model Number: DYNJ80849F;
36) WWD NEURO PACK, Model Number: DYNJ80849G;
37) WWD NEURO PACK, Model Number: DYNJ80849I;
38) WWD NEURO PACK, Model Number: DYNJ80849J;
39) NEURO DIAGNOSTIC, Model Number: DYNJ84653A;
40) NEURO, Model Number: DYNJ900904J;
41) NEURO, Model Number: DYNJ900904K;
42) NEURO, Model Number: DYNJ900904L;
43) NEURO, Model Number: DYNJ900904M;
44) NEURO, Model Number: DYNJ902585;
45) NEURO, Model Number: DYNJ902585A;
46) NEURO - IFCAP 230316, Model Number: DYNJ908393;
47) NEURO - IFCAP 230316, Model Number: DYNJ908393A;
48) NEURO - IFCAP 230316, Model Number: DYNJ908393B;
49) NEURO KIT, Model Number: DYNJ909573;
50) NEURO, Model Number: DYNJ910384;
51) NEURO, Model Number: DYNJ910384A;
52) NEURO PACK-LF, Model Number: PHS390015M |
|---|
| Code Information |
1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21CBA213;
2) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21DBD719;
3) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMA403;
4) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GME436;
5) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMF497;
6) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21JMH357;
7) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21KMD971;
8) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21LMG598;
9) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22DMD555;
10) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22HMC764;
11) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22KMF991;
12) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23AMJ086;
13) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMD444;
14) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970;
15) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23EME270;
16) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23GMC110;
17) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23IME897;
18) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMA572;
19) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMI786;
20) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23KMB758;
21) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24CMA817;
22) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24EMI161;
23) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24IMH330;
24) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24LMB440;
25) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 25CMC121;
26) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 25FMC026;
27) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABL131;
28) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABU817;
29) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBA521;
30) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBP552;
31) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21DBE120;
32) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21FBE311;
33) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBG761;
34) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBS468;
35) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21HBN643;
36) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21JBB951;
37) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21LBL164;
38) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22BBT015;
39) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22DBD203;
40) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBA074;
41) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBO542;
42) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBC967;
43) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBF303;
44) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22IBE871;
45) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22NBA962;
46) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22OBC508;
47) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABL138;
48) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABW870;
49) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBB221;
50) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBG852;
51) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22IBN422;
52) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22KBB452;
53) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22LBR466;
54) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23ABU154;
55) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23BBU041;
56) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBG764;
57) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBP083;
58) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23DBF392;
59) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23FBE493;
60) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23GBE625;
61) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23HBT876;
62) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23IBS183;
63) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23KBK072;
64) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24ABL221;
65) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBA173;
66) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBU410;
67) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24DBJ890;
68) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24EBQ164;
69) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24GBS072;
70) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24JBS893;
71) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBA532;
72) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBK044;
73) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24LBI083;
74) DYKMBNDL145, UDI-DI: 10193489478365(each), 40193489478366(case), Lot Number: 21ABT643;
75) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 22LBR481;
76) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 23EBU571;
77) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 23GBE626;
78) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 23GBS954;
79) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 23HBC122;
80) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 23HBH308;
81) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 23JBQ486;
82) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 23LBH331;
83) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24ABH120;
84) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24ABT109;
85) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24HBF314;
86) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24KBB216;
87) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24LBL113;
88) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 25BBG293;
89) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 25CBS910;
90) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 25DBI287;
91) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 25FBH445;
92) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 25GBF152;
93) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 25GBF317;
94) DYKMBNDL5, UDI-DI: 10193489477634(each), 40193489477635(case), Lot Number: 21ABQ194;
95) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 22IBJ928;
96) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23ABK051;
97) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23EBB597;
98) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23FBP269;
99) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23LBL844;
100) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24BBG003;
101) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24DBJ607;
102) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24EBC897;
103) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24GBK951;
104) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBH040;
105) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBJ842;
106) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25BBM404;
107) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25DBO558;
108) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25FBD172;
109) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25HBO105;
110) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25KBQ729;
111) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBF833;
112) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBO559;
113) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22JBL998;
114) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22LBL870;
115) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22OBL140;
116) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23CBI776;
117) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23DBQ920;
118) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23EBW271;
119) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23GBD741;
120) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23IBR967;
121) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 23LBR942;
122) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24ABW618;
123) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24CBL727;
124) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24DBT971;
125) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24FMG901;
126) DYNJ0408776Y, UDI-DI: 10195327115852(each), 40195327115853(case), Lot Number: 23DBS739;
127) DYNJ04596K, UDI-DI: 10193489301342(each), 40193489301343(case), Lot Number: 23KMD949;
128) DYNJ0781823K, UDI-DI: 10193489919196(each), 40193489919197(case), Lot Number: 23IME718;
129) DYNJ35243L, UDI-DI: 10195327638733(each), 40195327638734(case), Lot Number: 24FMB808;
130) DYNJ49098I, UDI-DI: 10193489712100(each), 40193489712101(case), Lot Number: 21BBP868;
131) DYNJ53089B, UDI-DI: 10193489335248(each), 40193489335249(case), Lot Number: 21BBA722;
132) DYNJ53799, UDI-DI: 10889942444557(each), 40889942444558(case), Lot Number: 21ADA264;
133) DYNJ58704A, UDI-DI: 10193489502053(each), 40193489502054(case), Lot Number: 23CBT449;
134) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21GLB218;
135) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA233;
136) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA398;
137) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21KLA157;
138) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBI340;
139) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21CBC497;
140) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBJ319;
141) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBO518;
142) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR912;
143) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR913;
144) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21FBS847;
145) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 22ABJ128;
146) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22HBN525;
147) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22OBE182;
148) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23CBE668;
149) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23DBB793;
150) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23EBM305;
151) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23HBY836;
152) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23KBH242;
153) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23LBN124;
154) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23IBP298;
155) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23KBP559;
156) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23LBG606;
157) DYNJ61157D, UDI-DI: 10195327605919(each), 40195327605910(case), Lot Number: 24ABQ754;
158) DYNJ61157D, UDI-DI: 10195327605919(each), 40195327605910(case), Lot Number: 24BBH233;
159) DYNJ61157F, UDI-DI: 10195327690984(each), 40195327690985(case), Lot Number: 24EBO693;
160) DYNJ61157F, UDI-DI: 10195327690984(each), 40195327690985(case), Lot Number: 24GBA775;
161) DYNJ61157F, UDI-DI: 10195327690984(each), 40195327690985(case), Lot Number: 24IBA986;
162) DYNJ61157F, UDI-DI: 10195327690984(each), 40195327690985(case), Lot Number: 24IBQ450;
163) DYNJ61157F, UDI-DI: 10195327690984(each), 40195327690985(case), Lot Number: 24KBM686;
164) DYNJ61157F, UDI-DI: 10195327690984(each), 40195327690985(case), Lot Number: 24LBL683;
165) DYNJ61157F, UDI-DI: 10195327690984(each), 40195327690985(case), Lot Number: 25CBK270;
166) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24CBB175;
167) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24GBA833;
168) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24IBQ689;
169) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25ABG065;
170) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25CBH417;
171) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25EBE757;
172) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25FBF194;
173) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25GBR898;
174) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBG888;
175) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBR218;
176) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25KBL642;
177) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21DBV445;
178) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21KBA371;
179) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB713;
180) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB714;
181) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBE011;
182) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22ABL607;
183) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBP375;
184) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBX534;
185) DYNJ61998, UDI-DI: 10193489615012(each), 40193489615013(case), Lot Number: 23EBV072;
186) DYNJ64570A, UDI-DI: 10195327242800(each), 40195327242801(case), Lot Number: 22LBK925;
187) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22EBL897;
188) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22GBR040;
189) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22IBV281;
190) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22LBK279;
191) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23BBS499;
192) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBR140;
193) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBT224;
194) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23DBP210;
195) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23FBJ662;
196) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23GBG567;
197) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 24CBB478;
198) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 24GBQ829;
199) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 24IBL709;
200) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 24JBR686;
201) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 24LBR882;
202) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 25BBD822;
203) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 25BBH829;
204) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 25EBR504;
205) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 25FBO441;
206) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 25HBO015;
207) DYNJ80442B, UDI-DI: 10195327516338(each), 40195327516339(case), Lot Number: 25HBS113;
208) DYNJ80849B, UDI-DI: 10195327443689(each), 40195327443680(case), Lot Number: 23GBF525;
209) DYNJ80849B, UDI-DI: 10195327443689(each), 40195327443680(case), Lot Number: 23HBR538;
210) DYNJ80849C, UDI-DI: 10195327518561(each), 40195327518562(case), Lot Number: 23JBE317;
211) DYNJ80849C, UDI-DI: 10195327518561(each), 40195327518562(case), Lot Number: 23KBI537;
212) DYNJ80849D, UDI-DI: 10195327579289(each), 40195327579280(case), Lot Number: 24ABE404;
213) DYNJ80849D, UDI-DI: 10195327579289(each), 40195327579280(case), Lot Number: 24CBC623;
214) DYNJ80849D, UDI-DI: 10195327579289(each), 40195327579280(case), Lot Number: 24DBQ059;
215) DYNJ80849F, UDI-DI: 10198459032165(each), 40198459032166(case), Lot Number: 24GBO690;
216) DYNJ80849F, UDI-DI: 10198459032165(each), 40198459032166(case), Lot Number: 24HBM361;
217) DYNJ80849F, UDI-DI: 10198459032165(each), 40198459032166(case), Lot Number: 24JBJ479;
218) DYNJ80849G, UDI-DI: 10198459166129(each), 40198459166120(case), Lot Number: 24LBK924;
219) DYNJ80849I, UDI-DI: 10198459233159(each), 40198459233150(case), Lot Number: 25ABS617;
220) DYNJ80849I, UDI-DI: 10198459233159(each), 40198459233150(case), Lot Number: 25CBQ272;
221) DYNJ80849I, UDI-DI: 10198459233159(each), 40198459233150(case), Lot Number: 25GBE969;
222) DYNJ80849J, UDI-DI: 10198459561245(each), 40198459561246(case), Lot Number: 25KBJ851;
223) DYNJ84653A, UDI-DI: 10195327697419(each), 40195327697410(case), Lot Number: 24GBU616;
224) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21GBF913;
225) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21HBI172;
226) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21JBQ824;
227) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21LBG281;
228) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22CLA766;
229) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22EBB675;
230) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22ELA806;
231) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ991;
232) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ992;
233) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBR893;
234) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22JBY355;
235) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22KBC323;
236) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22OBE679;
237) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABC415;
238) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABR127;
239) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBN975;
240) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBV444;
241) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23GBW505;
242) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23HBQ501;
243) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23JBF549;
244) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23KBH986;
245) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24ABH283;
246) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24CBN849;
247) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMB555;
248) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMH051;
249) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24FMF700;
250) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24HMA754;
251) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMB004;
252) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMF168;
253) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24KMG047;
254) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24LMD278;
255) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25AMG870;
256) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25BME471;
257) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25CMJ212;
258) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25DME524;
259) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMG513;
260) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMJ902;
261) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25FMG005;
262) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25GMI512;
263) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25HMI564;
264) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21CDB697;
265) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21EDA724;
266) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21FDA224;
267) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21GDB745;
268) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21IDB884;
269) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21JDC066;
270) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21LDA963;
271) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22FDB376;
272) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22GDB053;
273) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22HDB311;
274) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22IDA639;
275) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23ADA425;
276) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23FDA576;
277) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23IDB360;
278) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24CDA135;
279) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24GDA318;
280) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24JDC387;
281) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24LDA154;
282) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25ADA139;
283) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25DDB556;
284) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22BDB502;
285) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22EDA370;
286) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDA427;
287) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDB437;
288) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22HDC481;
289) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDA609;
290) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDB239;
291) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22LDA043;
292) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23BDB148;
293) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23EDB018;
294) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23FDB736;
295) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23GDA913;
296) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23HDC123;
297) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23HDC701;
298) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 23KDA234;
299) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 24BDA090;
300) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 24CDB967;
301) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 24EDB090;
302) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 24EDC063;
303) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 24IDA719;
304) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 24JDA510;
305) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 24KDB904;
306) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25CDA661;
307) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25DDC013;
308) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25EDA457;
309) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25FDB472;
310) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25HDA240;
311) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25LDA938;
312) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25KDB530;
313) DYNJ908393B, UDI-DI: 10198459118920(each), 40198459118921(case), Lot Number: 25IDB199;
314) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25DLA489;
315) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25FLA327;
316) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24EBH096;
317) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24FBF785;
318) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 24JBQ224;
319) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25ABA025;
320) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25BBN770;
321) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF584;
322) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF621;
323) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25DBC086;
324) PHS390015M, UDI-DI: 10193489333824(each), 40193489333825(case), Lot Number: 20LMD456 |
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
|---|
Manufacturer Reason
for Recall | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.
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 form.
Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1
Recall Code:
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 and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
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. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
An URGENT MEDICAL DEVICE RECALL notification letter dated 1/14/26 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.
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 form.
Website link: https://recalls.medline.com
Recall Reference #: R-26-003- |
|---|
| Quantity in Commerce | 10184 units |
|---|
| Distribution | Worldwide - US Nationwide distribution. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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