| | Class 2 Device Recall Medline Convenience Kits |  |
| Date Initiated by Firm | January 07, 2026 |
| Date Posted | February 17, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1397-2026 |
| Recall Event ID |
98329 |
| Product Classification |
Plastic surgery and accessories kit - Product Code FTN
|
| Product | Medline Convenience Kits:
1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499;
2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C;
3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;
4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170;
5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A;
6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B;
7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;
8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A;
9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B;
10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183;
11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A;
12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B;
13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A;
14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39;
15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A;
16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C;
17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46;
18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54;
19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69;
20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A;
21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B;
22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78;
23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A;
24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B;
25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84;
26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C;
27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G;
28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J;
29) BREAST PACK ASC-LF, Model Number: DYNJ36469I;
30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J;
31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F;
32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K;
33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M;
34) BREAST PACK, Model Number: DYNJ50957G;
35) PLASTICS BREAST PACK, Model Number: DYNJ55358G;
36) BHN IMPLANT PACK, Model Number: DYNJ56737A;
37) BREAST PACK, Model Number: DYNJ60210A;
38) PLASTICS PACK 2, Model Number: DYNJ64927F;
39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A;
40) BREAST IMPLANT PACK, Model Number: DYNJ69351;
41) BREAST/TUMMY PACK, Model Number: DYNJ83788;
42) HMSL PLASTICS, Model Number: DYNJ83884B;
43) CHEST/BREAST-LF, Model Number: DYNJ83950A;
44) CHEST/BREAST-LF, Model Number: DYNJ83950B;
45) FREE FLAP A DIRTY, Model Number: DYNJ86165;
46) MAJOR SURGERY PACK, Model Number: DYNJ86816;
47) BREAST REDUCTION PACK, Model Number: DYNJ87444;
48) OMF FREE FLAP, Model Number: DYNJ902005I;
49) BREAST CDS, Model Number: DYNJ902558G;
50) TRUNCAL CONTOURING, Model Number: DYNJ903555D;
51) TRUNCAL CONTOURING, Model Number: DYNJ903555F;
52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C;
53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A;
54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A;
55) FACELIFT, Model Number: DYNJ910462;
56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283;
57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417;
58) PLASTICS PACK-LF, Model Number: PHS806973G |
| Code Information |
1) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702;
2) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDA228;
3) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25ADB705;
4) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24JDA650;
5) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24IDA403;
6) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23LDC086;
7) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23IDB182;
8) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23HDB786;
9) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21JDB530;
10) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21HDB434;
11) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21GDB740;
12) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21FDA888;
13) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21DDA661;
14) DYKMBNDL117C, UDI-DI: 10195327371104(each), 40195327371105(case), Lot Number: 23DLA834;
15) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21CBE548;
16) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21ABI978;
17) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22IBC515;
18) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22HBN456;
19) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22EBA143;
20) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21IBV640;
21) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21DBN049;
22) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21BBH637;
23) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21ABJ202;
24) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 20LBY951;
25) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23IBB851;
26) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBG507;
27) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBB877;
28) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23GBR888;
29) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 22JBM366;
30) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25LBM160;
31) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25KBR870;
32) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25GBA895;
33) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25EBM448;
34) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBS731;
35) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBK034;
36) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBN216;
37) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBA340;
38) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24IBB931;
39) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBL546;
40) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBD539;
41) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 23LBI220;
42) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22FBC879;
43) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22EBO665;
44) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22BBN306;
45) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21DBC569;
46) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABX025;
47) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABI990;
48) DYKMBNDL182A, UDI-DI: 10195327633806(each), 40195327633807(case), Lot Number: 24BBN507;
49) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25FBO935;
50) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25ABL533;
51) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24KBS891;
52) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBQ469;
53) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBL678;
54) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24DBR913;
55) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21JBJ252;
56) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21CBG305;
57) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21ABI992;
58) DYKMBNDL183A, UDI-DI: 10195327246594(each), 40195327246595(case), Lot Number: 23BBI487;
59) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24GBC829;
60) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBT970;
61) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBJ591;
62) DYKMBNDL34A, UDI-DI: 10193489872033(each), 40193489872034(case), Lot Number: 21DBQ512;
63) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22IBC434;
64) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22GBM861;
65) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22BBU074;
66) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21LBJ742;
67) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21GBR352;
68) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21CBD335;
69) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21ABJ002;
70) DYKMBNDL39A, UDI-DI: 10195327241308(each), 40195327241309(case), Lot Number: 23ABH677;
71) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 25GBW751;
72) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 24JBO020;
73) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21GBR353;
74) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21BBM839;
75) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21ABL308;
76) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21CBG791;
77) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21BBH629;
78) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABO607;
79) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABM089;
80) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABJ589;
81) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 20LBY967;
82) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22JBC409;
83) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22IBR235;
84) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBQ100;
85) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBN457;
86) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21JBS176;
87) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21IBV702;
88) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBO272;
89) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBM983;
90) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBK340;
91) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21GBR324;
92) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21DBC571;
93) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABL345;
94) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABJ013;
95) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23LBA275;
96) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23JBJ695;
97) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23GBL960;
98) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23FBP246;
99) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22KBO876;
100) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBQ852;
101) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBJ150;
102) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC626;
103) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC618;
104) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25KBP763;
105) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25GBL984;
106) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25FBH462;
107) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24KBT018;
108) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24HBM099;
109) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24GBF481;
110) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24EBR715;
111) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22EBS816;
112) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22CBX537;
113) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22BBL848;
114) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABL251;
115) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABG018;
116) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBY278;
117) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBO572;
118) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21KBY757;
119) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21JBJ751;
120) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBV643;
121) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBB097;
122) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21HBK310;
123) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBR398;
124) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBF907;
125) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21DBC549;
126) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21BBK531;
127) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABX017;
128) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABJ216;
129) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 20XBB257;
130) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23LBE774;
131) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23JBN862;
132) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBP831;
133) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBO451;
134) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22KBO921;
135) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBQ856;
136) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ143;
137) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ019;
138) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25FBP527;
139) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBM007;
140) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBE325;
141) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25CBG915;
142) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBU089;
143) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBO685;
144) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBE752;
145) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24LBL035;
146) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24HBD157;
147) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBU597;
148) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBE953;
149) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBR114;
150) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBF892;
151) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22OBH455;
152) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22IBC435;
153) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22HBO907;
154) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBT013;
155) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBF307;
156) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBH705;
157) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBD628;
158) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21JBH111;
159) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21IBT011;
160) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBR338;
161) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBF538;
162) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21EBH614;
163) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21CBM835;
164) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABU822;
165) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABM088;
166) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBQ326;
167) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBP864;
168) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25HBG553;
169) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25GBF486;
170) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25FBB154;
171) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25DBO560;
172) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBS883;
173) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBI135;
174) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24JBE336;
175) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24IBE175;
176) DYNJ0785310G, UDI-DI: 10193489268966(each), 40193489268967(case), Lot Number: 23KMH075;
177) DYNJ0854650J, UDI-DI: 10193489832426(each), 40193489832427(case), Lot Number: 24IMF274;
178) DYNJ36469I, UDI-DI: 10195327513931(each), 40195327513932(case), Lot Number: 24BBU341;
179) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21CDB475;
180) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21BDB779;
181) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21ADA533;
182) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24KMD041;
183) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24IME867;
184) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24GMA471;
185) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24DMJ046;
186) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24CMD088;
187) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24AMI035;
188) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23LMB124;
189) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23KMA468;
190) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23IMG016;
191) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23HMA900;
192) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23AME665;
193) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22IMF713;
194) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22HMH034;
195) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22GMF684;
196) DYNJ44852K, UDI-DI: 10195327127589(each), 40195327127580(case), Lot Number: 22CMI118;
197) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25EME929;
198) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25CME690;
199) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24KME600;
200) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24GMI186;
201) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24CMC758;
202) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24AMB315;
203) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23HME689;
204) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23FMH424;
205) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23DMD096;
206) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23CMF343;
207) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC530;
208) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC374;
209) DYNJ50957G, UDI-DI: 10193489448863(each), 40193489448864(case), Lot Number: 23GBV065;
210) DYNJ55358G, UDI-DI: 10195327173500(each), 40195327173501(case), Lot Number: 23FBN323;
211) DYNJ56737A, UDI-DI: 10193489395594(each), 40193489395595(case), Lot Number: 23CME388;
212) DYNJ60210A, UDI-DI: 10193489985108(each), 40193489985109(case), Lot Number: 21KBP457;
213) DYNJ64927F, UDI-DI: 10195327143091(each), 40195327143092(case), Lot Number: 23FBV335;
214) DYNJ68844A, UDI-DI: 10195327216504(each), 40195327216505(case), Lot Number: 23HMB858;
215) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 24BBL537;
216) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23KBN973;
217) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23JBU455;
218) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23HBY228;
219) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23CBG820;
220) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBP453;
221) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBD661;
222) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 21LBP376;
223) DYNJ83788, UDI-DI: 10195327305833(each), 40195327305834(case), Lot Number: 23CBO212;
224) DYNJ83884B, UDI-DI: 10198459234620(each), 40198459234621(case), Lot Number: 25GBO120;
225) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 25ABF915;
226) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24JBV233;
227) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24FBL440;
228) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24EBR736;
229) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25DBT195;
230) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25CBF253;
231) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25ABT952;
232) DYNJ86165, UDI-DI: 10195327599324(each), 40195327599325(case), Lot Number: 25ABJ747;
233) DYNJ86816, UDI-DI: 10195327679903(each), 40195327679904(case), Lot Number: 24FMB609;
234) DYNJ87444, UDI-DI: 10198459040122(each), 40198459040123(case), Lot Number: 24GBQ988;
235) DYNJ902005I, UDI-DI: 10195327347710(each), 40195327347711(case), Lot Number: 24DLA844;
236) DYNJ902558G, UDI-DI: 10193489728859(each), 40193489728850(case), Lot Number: 23HMG989;
237) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22HBF672;
238) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22GBT713;
239) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP519;
240) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP518;
241) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBG876;
242) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23FBN475;
243) DYNJ903849C, UDI-DI: 10195327333355(each), 40195327333356(case), Lot Number: 23DBS608;
244) DYNJ907847A, UDI-DI: 10193489937589(each), 40193489937580(case), Lot Number: 23IMF989;
245) DYNJ907874A, UDI-DI: 10195327241247(each), 40195327241248(case), Lot Number: 23FLA249;
246) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24JMD608;
247) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24IMF741;
248) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24GME383;
249) DYNJT3283, UDI-DI: 10198459323645(each), 40198459323646(case), Lot Number: 25JBI499;
250) DYNJT3417, UDI-DI: 10198459324888(each), 40198459324889(case), Lot Number: 25EBN203;
251) PHS806973G, UDI-DI: 10193489926996(each), 40193489926997(case), Lot Number: 23EBQ702 |
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 | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes.
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. Upon completion of the below actions, please destroy 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 response form.
Website link: https://recalls.medline.com
Recall Reference #: R-26-003
Recall Code:
3. Your account will receive credit once the response form is submitted.
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 request that customers destroy any affected product. You should include your customers quantities on your response form.
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 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes.
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, |
| Quantity in Commerce | 4757 units |
| Distribution | Worldwide distribution - US Nationwide. |
| 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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