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Urgent Enforcement Amended Final

Medline Recalls 41 Surgical Kit Models Under Class II Recall Z-1842-2026

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Summary

FDA initiated Class II recall Z-1842-2026 for 41 Medline surgical kit models due to device classification as General Surgery Trays (Product Code LRO). The recall was initiated by the firm on February 25, 2026 and posted on April 17, 2026 with Open status. Affected products include model numbers DYKB1038, DYNDA3188, DYNJG001027B, DYNJTUMSYR, DYNJT3719, DYNJT5667, and 35 additional surgical kit configurations, distributed with specific lot numbers and UDI-DI codes spanning multiple production dates from 2021 through 2025.

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What changed

FDA classified a Class II device recall for 41 Medline surgical kit models used in general surgery procedures. The recall affects multiple product configurations including newborn admission kits, drainage trays, cardiac cath packs, angiography packs, and extremity packs, among others. Affected healthcare facilities and distributors should verify their inventory against the specific model numbers, lot numbers, and UDI-DI codes provided in the recall notice. Firms with affected product should follow established recall response procedures and coordinate with Medline regarding return or correction of affected devices.

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Apr 21, 2026

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Class 2 Device Recall Medline Kits

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Date Initiated by Firm February 25, 2026
Date Posted April 17, 2026
Recall Status Open , Classified
Recall Number Z-1842-2026
Recall Event ID 98599
Product Classification General surgery tray - Product Code LRO
Product Medline Kits:

1) NEWBORN ADMISSION, Model Number: DYKB1038;
2) DRAINAGE TRAY, Model Number: DYNDA3188;
3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B;
4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR;
5) OMC PTCA PACK, Model Number: DYNJT3719;
6) PORT PACK, Model Number: DYNJT5667;
7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2;
8) CARDIAC CATH, Model Number: DYNJ20175J;
9) D&C PACK-POB, Model Number: DYNJ33521D;
10) BASIC PACK, Model Number: DYNJ38533F;
11) CATH PACK IMPLANT, Model Number: DYNJ39230D;
12) CERVICAL SPINE PACK, Model Number: DYNJ40886B;
13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F;
14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D;
15) MAJOR PACK-LF, Model Number: DYNJ44816J;
16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A;
17) EXTREMITY PACK, Model Number: DYNJ55922C;
18) NEURO PACK, Model Number: DYNJ57785C;
19) PACEMAKER PACK, Model Number: DYNJ61377B;
20) VASCULAR PACK, Model Number: DYNJ62683D;
21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B;
22) BASIC PACK, Model Number: DYNJ83324;
23) OMF MINOR PACK, Model Number: DYNJ83991B;
24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B;
25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600;
26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064;
27) RADIOLOGY PACK, Model Number: DYNJ89080;
28) LITHOTOMY PACK, Model Number: DYNJ89959;
29) AHT SPINE PACK, Model Number: DYNJ903566D;
30) LAP, Model Number: DYNJ904576B;
31) EP MERCY JANESVILLE, Model Number: DYNJ907013;
32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032;
33) CHERIAN CATH KIT, Model Number: VASC1086;
34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120;
35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151;
36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155;
37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404;
38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405;
39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A;
40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533;
41) ARTERIOGRAM TRAY, Model Number: 00-402001V |
| Code Information | 1) DYKB1038, UDI-DI: 10193489502428(each), 40193489502429(case), Lot Number: 22GBJ869;
2) DYNDA3188, UDI-DI: 10198459303579(each), 40198459303570(case), Lot Number: 25DBF256;
3) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA998;
4) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA723;
5) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBH579;
6) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBS213;
7) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21DBS220;
8) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21HBK178;
9) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21IBV194;
10) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBJ063;
11) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBM583;
12) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABG678;
13) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABZ724;
14) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22DBL342;
15) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22IBS978;
16) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22JBV884;
17) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22LBH141;
18) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE023;
19) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE024;
20) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE025;
21) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23CBP389;
22) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBB429;
23) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBQ437;
24) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23GBB278;
25) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23HBD985;
26) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23JBN242;
27) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP034;
28) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP432;
29) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABA416;
30) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24EBF244;
31) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBB647;
32) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBO960;
33) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBE249;
34) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBW947;
35) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24HBN439;
36) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24JBC123;
37) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24KBI920;
38) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24LBO860;
39) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBV362;
40) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23BBU890;
41) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABN982;
42) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 25HBM032;
43) DYNJT3719, UDI-DI: 10198459347054(each), 40198459347055(case), Lot Number: 25EBU996;
44) DYNJT5667, UDI-DI: 10198459492129(each), 40198459492120(case), Lot Number: 25HDB174;
45) DYNJWASTEKIT2, UDI-DI: 10193489548204(each), 40193489548205(case), Lot Number: 22HBK640;
46) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25DMI117;
47) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25BMC155;
48) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24FDB534;
49) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24HDC006;
50) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24IDB770;
51) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24KDA884;
52) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24LDA938;
53) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25ADB529;
54) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25BDB719;
55) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25DDB454;
56) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25HDA895;
57) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24DBD251;
58) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24EBF801;
59) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24FBD925;
60) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBY008;
61) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24HBN127;
62) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24JBT025;
63) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24KBF095;
64) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24LBK225;
65) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25BBA827;
66) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25CBF946;
67) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25DBH070;
68) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25EBK903;
69) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBC776;
70) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25GBS410;
71) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25BBB333;
72) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25CBI608;
73) DYNJ40886B, UDI-DI: 10193489768282(each), 40193489768283(case), Lot Number: 25ELA632;
74) DYNJ41553F, UDI-DI: 10198459079634(each), 40198459079635(case), Lot Number: 25EMI492;
75) DYNJ41558D, UDI-DI: 10889942811663(each), 40889942811664(case), Lot Number: 25EMC747;
76) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24HBE996;
77) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24IBD804;
78) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24JBH568;
79) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 25EBR969;
80) DYNJ48683A, UDI-DI: 10889942491377(each), 40889942491378(case), Lot Number: 24LBO769;
81) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25FMA909;
82) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25EMJ828;
83) DYNJ57785C, UDI-DI: 10195327543624(each), 40195327543625(case), Lot Number: 24BBN969;
84) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24CBB176;
85) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24DBR422;
86) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24FBO638;
87) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24HBT927;
88) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24IBP969;
89) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24JBH473;
90) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24KBG036;
91) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25CBH396;
92) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25EBE869;
93) DYNJ62683D, UDI-DI: 10195327556518(each), 40195327556519(case), Lot Number: 24ABP681;
94) DYNJ63668B, UDI-DI: 10195327550851(each), 40195327550852(case), Lot Number: 24HME110;
95) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23BMD400;
96) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23AMA569;
97) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24HBS684;
98) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBP876;
99) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBS147;
100) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24LBL583;
101) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25CBP938;
102) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25DBQ919;
103) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25FBD407;
104) DYNJ84040B, UDI-DI: 10198459254161(each), 40198459254162(case), Lot Number: 25BMG397;
105) DYNJ86600, UDI-DI: 10198459021565(each), 40198459021566(case), Lot Number: 25BBT025;
106) DYNJ89064, UDI-DI: 10198459230820(each), 40198459230821(case), Lot Number: 25ABL031;
107) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25ABS218;
108) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25BBC477;
109) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25CBC491;
110) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25DBC830;
111) DYNJ89959, UDI-DI: 10198459300912(each), 40198459300913(case), Lot Number: 25DBD397;
112) DYNJ903566D, UDI-DI: 10195327560829(each), 40195327560820(case), Lot Number: 25HBU069;
113) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21FBN722;
114) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21HBI274;
115) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21IBL093;
116) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21KBE009;
117) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21LBG338;
118) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22GBZ027;
119) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22JMB507;
120) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22KMC060;
121) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23BMF719;
122) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23CME266;
123) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMI182;
124) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23GMI509;
125) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23JME302;
126) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23KMI130;
127) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23LMH540;
128) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24BMA155;
129) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24GME966;
130) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24IMC690;
131) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24KMG557;
132) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21GBO411;
133) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMC753;
134) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 25GMD612;
135) DYNJ907013, UDI-DI: 10193489318630(each), 40193489318631(case), Lot Number: 25FLA929;
136) NAM0032, UDI-DI: 10195327694357(each), 40195327694358(case), Lot Number: 24LBG464;
137) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21DBF029;
138) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21GBV041;
139) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21IBQ150;
140) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21KBK856;
141) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21LBA326;
142) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22CBX005;
143) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22EBO968;
144) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22HBF991;
145) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22IBR901;
146) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABL896;
147) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABN264;
148) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBA069;
149) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBM493;
150) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23EBH545;
151) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23FBF982;
152) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23HBE007;
153) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23IBE867;
154) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23JBW353;
155) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24ABL399;
156) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBB750;
157) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBP944;
158) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24EBQ247;
159) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24FBB644;
160) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24HBV207;
161) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24KBI912;
162) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25CBQ305;
163) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25DBK904;
164) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22JBD604;
165) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23KBG280;
166) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25EBH405;
167) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 25EBV199;
168) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 24FBD352;
169) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBM012;
170) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBD891;
171) VASC1155, UDI-DI: 10888277760493(each), 40888277760494(case), Lot Number: 25GBN921;
172) VASC1404, UDI-DI: 10195327366568(each), 40195327366569(case), Lot Number: 23EBI565;
173) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25GBS655;
174) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25DBJ392;
175) VASC1415A, UDI-DI: 10195327678272(each), 40195327678273(case), Lot Number: 24LBH191;
176) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24GBM956;
177) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24HBN734;
178) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24JBS224;
179) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24LBL061;
180) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25BBQ097;
181) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBK254;
182) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBN756;
183) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBU919;
184) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25DBG067;
185) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24FBQ508;
186) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25EBQ528;
187) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25ABG557;
188) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25BBE970;
189) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25CBN926;
190) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBD516;
191) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBP919 |
| 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 | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| FDA Determined
Cause | No Marketing Application |
| Action | An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers.

REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product.
2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to
Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1
Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit.
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. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers.
Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com.

*** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers.

This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification.

REQUIRED ACTIONS:
same as for 2/25/26 letter |
| Quantity in Commerce | 38014 units |
| Distribution | 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. | |

Parties

Medline

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Classification

Agency
FDA
Filed
April 17th, 2026
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Surgical kit distribution Product correction
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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