| | Class 2 Device Recall MEDLINE |  |
| Date Initiated by Firm | September 30, 2025 |
|---|
| Date Posted | November 14, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0517-2026 |
|---|
| Recall Event ID |
97846 |
| Product Classification |
laparoscopy kit - Product Code FDE
|
| Product | MEDLINE convenience kits labeled as:
1) MAJOR LAPAROTOMY CDS, REF CDS860015W;
2) MAJOR LAPAROTOMY CDS, REF CDS860015X;
3) MINOR LAPAROTOMY CDS, REF CDS860016R;
4) MINOR LAPAROTOMY CDS, REF CDS860016S;
5) LAPAROTOMY CDS #31-RF, REF CDS860062S;
6) LAPAROSCOPY CDS, REF CDS860194I;
7) BASIC LAPAROSCOPY CDS, REF CDS920080T;
8) GENERAL LAPAROSCOPY, REF CDS930027V;
9) GENERAL LAPAROSCOPY, REF CDS930027X;
10) GENERAL MINOR CDS, REF CDS980246V;
11) BASIC CDS, REF CDS982936V;
12) MAJOR ABDOMINAL CDS, REF CDS983759L;
13) GENERAL SURGERY CDS, REF CDS983914L;
14) GENERAL LAP, REF CDS984251N;
15) ACH MINOR PROCEDURE, REF CDS985451G;
16) SCOPE LAP THOR PACK, REF DYNJ00210N;
17) MAJOR LAPAROTOMY PACK, REF DYNJ00387P;
18) MAJOR ABDOMINAL HARPER PACK-LF, REF DYNJ0160657D;
19) LAPAROTOMY PACK-LF, REF DYNJ0161299C;
20) LAPAROTOMY PACK-LF, REF DYNJ0311538N;
21) MAJOR PACK-LF, REF DYNJ0386381L;
22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N;
23) LAPAROTOMY PACK-LF, REF DYNJ0519288N;
24) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S;
25) MAJOR LAPAROTOMY PACK, REF DYNJ20819M;
26) MAJOR ABDOMINAL, REF DYNJ23429G;
27) MINI LAPAROTOMY #16-RF, REF DYNJ27322S;
28) MINI LAPAROTOMY #16-RF, REF DYNJ27322T;
29) TN LAPAROTOMY PACK-LF, REF DYNJ34206I;
30) LAPAROTOMY, REF DYNJ34424N;
31) COREWELL TSC- LAP PACK-LF, REF DYNJ37100I;
32) GENERAL LAP PACK, REF DYNJ38223C;
33) LAP CHOLE PACK, REF DYNJ38228C;
34) MINOR PACK, REF DYNJ41418I;
35) GENERAL PACK-LF, REF DYNJ43213J;
36) HERNIA PACK, REF DYNJ44683L;
37) GENERAL ABDOMINAL, REF DYNJ44870J;
38) LAP CHOLE PACK, REF DYNJ44873I;
39) LAP RENAL PACK, REF DYNJ44875O;
40) MAJOR LAPAROTOMY, REF DYNJ45334G;
41) MAJOR LAPAROTOMY, REF DYNJ45334J;
42) MINOR PROCEDURE, REF DYNJ45336J;
43) MINOR PROCEDURE PACK, REF DYNJ47057D;
44) MINOR PROCEDURE PACK, REF DYNJ47057F;
45) MAJOR BASIC PACK (MBGSE)227-LF, REF DYNJ47696J;
46) LAP CHOLE PACK, REF DYNJ48092G;
47) LAPAROTOMY PACK, REF DYNJ48093F;
48) ISS GENERAL PACK, REF DYNJ48921I;
49) MINOR UROLOGY PACK, REF DYNJ49310F;
50) HERNIA SGM PACK-LF, REF DYNJ51434B;
51) MINOR GENERAL PACK, REF DYNJ52329C;
52) MINOR GENERAL PACK, REF DYNJ52329D;
53) MINOR GENERAL PACK, REF DYNJ52329F;
54) MINOR LAPAROTOMY PACK-LF, REF DYNJ52863D;
55) MINOR GENERAL PACK, REF DYNJ53036G;
56) MINOR GENERAL PACK, REF DYNJ53036I;
57) IPP PENILE PROSTHESIS PACK, REF DYNJ58061J;
58) MAJOR LAPAROTOMY PACK, REF DYNJ58561D;
59) MAJOR LAPAROTOMY PACK, REF DYNJ58561F;
60) MINOR PACK, REF DYNJ58562D;
61) MINOR PACK, REF DYNJ58562F;
62) MINOR GENERAL PACK, REF DYNJ59358D;
63) PACK HERNIA INGUINAL, REF DYNJ60145B;
64) PK CUST MAJOR ST MICHAEL, REF DYNJ60782B;
65) CENTRACARE PLAZA-LAP CHOLE PK, REF DYNJ61620C;
66) MINOR GEN PACK, REF DYNJ61661A;
67) SLCH MAJOR GENERAL PACK, REF DYNJ61666A;
68) DAVINCI PROSTATE PACK, REF DYNJ61711B;
69) THORACIC PACK, REF DYNJ62015C;
etc |
|---|
| Code Information |
REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W;
REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W;
REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W;
REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X;
REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X;
REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X;
REF CDS860016R: UDI/DI 10195327349479 (each) 40195327349470, (case), Lot Numbers: CDS860016R;
REF CDS860016S: UDI/DI 10195327647520 (each) 40195327647521, (case), Lot Numbers: CDS860016S;
REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S;
REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S;
REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S;
REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S;
REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S;
REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I;
REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I;
REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I;
REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I;
REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I;
REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I;
REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T;
REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T;
REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T;
REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T;
REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V;
REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V;
REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V;
REF CDS930027X: UDI/DI 10195327647698 (each) 40195327647699, (case), Lot Numbers: CDS930027X;
REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V;
REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V;
REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V;
REF CDS982936V: UDI/DI 10195327627324 (each) 40195327627325, (case), Lot Numbers: CDS982936V;
REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L;
REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L;
REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L;
REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L;
REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L;
REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L;
REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L;
REF CDS984251N: UDI/DI 10193489862218 (each) 40193489862219, (case), Lot Numbers: CDS984251N;
REF CDS984251N: UDI/DI 10193489862218 (each) 40193489862219, (case), Lot Numbers: CDS984251N;
REF CDS985451G: UDI/DI 10195327237639 (each) 40195327237630, (case), Lot Numbers: CDS985451G;
REF DYNJ00210N: UDI/DI 10195327412012 (each) 40195327412013, (case), Lot Numbers: DYNJ00210N;
REF DYNJ00210N: UDI/DI 10195327412012 (each) 40195327412013, (case), Lot Numbers: DYNJ00210N;
REF DYNJ00387P: UDI/DI 10195327412043 (each) 40195327412044, (case), Lot Numbers: DYNJ00387P;
REF DYNJ00387P: UDI/DI 10195327412043 (each) 40195327412044, (case), Lot Numbers: DYNJ00387P;
REF DYNJ0160657D: UDI/DI 10195327404543 (each) 40195327404544, (case), Lot Numbers: DYNJ0160657D;
REF DYNJ0161299C: UDI/DI 10195327357276 (each) 40195327357277, (case), Lot Numbers: DYNJ0161299C;
REF DYNJ0311538N: UDI/DI 10889942826612 (each) 40889942826613, (case), Lot Numbers: DYNJ0311538N;
REF DYNJ0311538N: UDI/DI 10889942826612 (each) 40889942826613, (case), Lot Numbers: DYNJ0311538N;
REF DYNJ0311538N: UDI/DI 10889942826612 (each) 40889942826613, (case), Lot Numbers: DYNJ0311538N;
REF DYNJ0386381L: UDI/DI 10195327219048 (each) 40195327219049, (case), Lot Numbers: DYNJ0386381L;
REF DYNJ0386381L: UDI/DI 10195327219048 (each) 40195327219049, (case), Lot Numbers: DYNJ0386381L;
REF DYNJ0386381L: UDI/DI 10195327219048 (each) 40195327219049, (case), Lot Numbers: DYNJ0386381L;
REF DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310, (case), Lot Numbers: DYNJ0426069N;
REF DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310, (case), Lot Numbers: DYNJ0426069N;
REF DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310, (case), Lot Numbers: DYNJ0426069N;
REF DYNJ0519288N: UDI/DI 10195327083960 (each) 40195327083961, (case), Lot Numbers: DYNJ0519288N;
REF DYNJ0519288N: UDI/DI 10195327083960 (each) 40195327083961, (case), Lot Numbers: DYNJ0519288N;
REF DYNJ0751401S: UDI/DI 10195327334185 (each) 40195327334186, (case), Lot Numbers: DYNJ0751401S;
REF DYNJ0751401S: UDI/DI 10195327334185 (each) 40195327334186, (case), Lot Numbers: DYNJ0751401S;
REF DYNJ20819M: UDI/DI 10195327191450 (each) 40195327191451, (case), Lot Numbers: DYNJ20819M;
REF DYNJ20819M: UDI/DI 10195327191450 (each) 40195327191451, (case), Lot Numbers: DYNJ20819M;
REF DYNJ23429G: UDI/DI 10195327528768 (each) 40195327528769, (case), Lot Numbers: DYNJ23429G;
REF DYNJ27322S: UDI/DI 10195327140649 (each) 40195327140640, (case), Lot Numbers: DYNJ27322S;
REF DYNJ27322T: UDI/DI 10195327580452 (each) 40195327580453, (case), Lot Numbers: DYNJ27322T;
REF DYNJ27322T: UDI/DI 10195327580452 (each) 40195327580453, (case), Lot Numbers: DYNJ27322T;
REF DYNJ27322T: UDI/DI 10195327580452 (each) 40195327580453, (case), Lot Numbers: DYNJ27322T;
REF DYNJ34206I: UDI/DI 10195327449124 (each) 40195327449125, (case), Lot Numbers: DYNJ34206I;
REF DYNJ34424N: UDI/DI 10195327610623 (each) 40195327610624, (case), Lot Numbers: DYNJ34424N;
REF DYNJ34424N: UDI/DI 10195327610623 (each) 40195327610624, (case), Lot Numbers: DYNJ34424N;
REF DYNJ37100I: UDI/DI 10195327449148 (each) 40195327449149, (case), Lot Numbers: DYNJ37100I;
REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C;
REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C;
REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C;
REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C;
REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C;
REF DYNJ38223C: UDI/DI 10195327381462 (each) 40195327381463, (case), Lot Numbers: DYNJ38223C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ38228C: UDI/DI 10195327381493 (each) 40195327381494, (case), Lot Numbers: DYNJ38228C;
REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I;
REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I;
REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I;
REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I;
REF DYNJ41418I: UDI/DI 10195327221003 (each) 40195327221004, (case), Lot Numbers: DYNJ41418I;
REF DYNJ43213J: UDI/DI 10193489953060 (each) 40193489953061, (case), Lot Numbers: DYNJ43213J;
REF DYNJ43213J: UDI/DI 10193489953060 (each) 40193489953061, (case), Lot Numbers: DYNJ43213J;
REF DYNJ44683L: UDI/DI 10195327127398 (each) 40195327127399, (case), Lot Numbers: DYNJ44683L;
REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J;
REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J;
REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J;
REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J;
REF DYNJ44870J: UDI/DI 10195327259686 (each) 40195327259687, (case), Lot Numbers: DYNJ44870J;
REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I;
REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I;
REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I;
REF DYNJ44873I: UDI/DI 10195327127671 (each) 40195327127672, (case), Lot Numbers: DYNJ44873I;
REF DYNJ44875O: UDI/DI 10195327127688 (each) 40195327127689, (case), Lot Numbers: DYNJ44875O;
REF DYNJ45334G: UDI/DI 10195327242541 (each) 40195327242542, (case), Lot Numbers: DYNJ45334G;
REF DYNJ45334J: UDI/DI 10195327507640 (each) 40195327507641, (case), Lot Numbers: DYNJ45334J;
REF DYNJ45336J: UDI/DI 10195327507480 (each) 40195327507481, (case), Lot Numbers: DYNJ45336J;
REF DYNJ45336J: UDI/DI 10195327507480 (each) 40195327507481, (case), Lot Numbers: DYNJ45336J;
REF DYNJ47057D: UDI/DI 10193489827569 (each) 40193489827560, (case), Lot Numbers: DYNJ47057D;
REF DYNJ47057D: UDI/DI 10193489827569 (each) 40193489827560, (case), Lot Numbers: DYNJ47057D;
REF DYNJ47057F: UDI/DI 10195327653415 (each) 40195327653416, (case), Lot Numbers: DYNJ47057F;
REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J;
REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J;
REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J;
REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J;
REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J;
REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J;
REF DYNJ47696J: UDI/DI 10195327509408 (each) 40195327509409, (case), Lot Numbers: DYNJ47696J;
REF DYNJ48092G: UDI/DI 10195327500146 (each) 40195327500147, (case), Lot Numbers: DYNJ48092G;
REF DYNJ48092G: UDI/DI 10195327500146 (each) 40195327500147, (case), Lot Numbers: DYNJ48092G;
REF DYNJ48092G: UDI/DI 10195327500146 (each) 40195327500147, (case), Lot Numbers: DYNJ48092G;
REF DYNJ48093F: UDI/DI 10195327500153 (each) 40195327500154, (case), Lot Numbers: DYNJ48093F;
REF DYNJ48093F: UDI/DI 10195327500153 (each) 40195327500154, (case), Lot Numbers: DYNJ48093F;
REF DYNJ48093F: UDI/DI 10195327500153 (each) 40195327500154, (case), Lot Numbers: DYNJ48093F;
REF DYNJ48921I: UDI/DI 10195327529826 (each) 40195327529827, (case), Lot Numbers: DYNJ48921I;
REF DYNJ48921I: UDI/DI 10195327529826 (each) 40195327529827, (case), Lot Numbers: DYNJ48921I;
REF DYNJ48921I: UDI/DI 10195327529826 (each) 40195327529827, (case), Lot Numbers: DYNJ48921I;
REF DYNJ49310F: UDI/DI 10195327546373 (each) 40195327546374, (case), Lot Numbers: DYNJ49310F;
REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B;
REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B;
REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B;
REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B;
REF DYNJ51434B: UDI/DI 10193489608915 (each) 40193489608916, (case), Lot Numbers: DYNJ51434B;
REF DYNJ52329C: UDI/DI 10195327237677 (each) 40195327237678, (case), Lot Numbers: DYNJ52329C;
REF DYNJ52329D: UDI/DI 10195327434069 (each) 40195327434060, (case), Lot Numbers: DYNJ52329D;
REF DYNJ52329F: UDI/DI 10195327484057 (each) 40195327484058, (case), Lot Numbers: DYNJ52329F;
REF DYNJ52329F: UDI/DI 10195327484057 (each) 40195327484058, (case), Lot Numbers: DYNJ52329F;
REF DYNJ52863D: UDI/DI 10195327191481 (each) 40195327191482, (case), Lot Numbers: DYNJ52863D;
REF DYNJ53036G: UDI/DI 10195327385842 (each) 40195327385843, (case), Lot Numbers: DYNJ53036G;
REF DYNJ53036G: UDI/DI 10195327385842 (each) 40195327385843, (case), Lot Numbers: DYNJ53036G;
REF DYNJ53036I: UDI/DI 10195327608354 (each) 40195327608355, (case), Lot Numbers: DYNJ53036I;
REF DYNJ58061J: UDI/DI 10195327463595 (each) 40195327463596, (case), Lot Numbers: DYNJ58061J;
REF DYNJ58061J: UDI/DI 10195327463595 (each) 40195327463596, (case), Lot Numbers: DYNJ58061J;
REF DYNJ58561D: UDI/DI 10193489972306 (each) 40193489972307, (case), Lot Numbers: DYNJ58561D;
REF DYNJ58561D: UDI/DI 10193489972306 (each) 40193489972307, (case), Lot Numbers: DYNJ58561D;
REF DYNJ58561D: UDI/DI 10193489972306 (each) 40193489972307, (case), Lot Numbers: DYNJ58561D;
REF DYNJ58561F: UDI/DI 10195327615215 (each) 40195327615216, (case), Lot Numbers: DYNJ58561F;
REF DYNJ58561F: UDI/DI 10195327615215 (each) 40195327615216, (case), Lot Numbers: DYNJ58561F;
REF DYNJ58561F: UDI/DI 10195327615215 (each) 40195327615216, (case), Lot Numbers: DYNJ58561F;
REF DYNJ58562D: UDI/DI 10193489972313 (each) 40193489972314, (case), Lot Numbers: DYNJ58562D;
REF DYNJ58562D: UDI/DI 10193489972313 (each) 40193489972314, (case), Lot Numbers: DYNJ58562D;
REF DYNJ58562F: UDI/DI 10195327615222 (each) 40195327615223, (case), Lot Numbers: DYNJ58562F;
REF DYNJ59358D: UDI/DI 10195327127824 (each) 40195327127825, (case), Lot Numbers: DYNJ59358D;
REF DYNJ59358D: UDI/DI 10195327127824 (each) 40195327127825, (case), Lot Numbers: DYNJ59358D;
REF DYNJ60145B: UDI/DI 10193489982848 (each) 40193489982849, (case), Lot Numbers: DYNJ60145B;
REF DYNJ60782B: UDI/DI 10195327361839 (each) 40195327361830, (case), Lot Numbers: DYNJ60782B;
REF DYNJ61620C: UDI/DI 10195327310011 (each) 40195327310012, (case), Lot Numbers: DYNJ61620C;
REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A;
REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A;
REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A;
REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A;
REF DYNJ61661A: UDI/DI 10193489929645 (each) 40193489929646, (case), Lot Numbers: DYNJ61661A;
REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A;
REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A;
REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A;
REF DYNJ61666A: UDI/DI 10193489929669 (each) 40193489929660, (case), Lot Numbers: DYNJ61666A;
REF DYNJ61711B: UDI/DI 10193489874723 (each) 40193489874724, (case), Lot Numbers: DYNJ61711B;
REF DYNJ62015C: UDI/DI 10195327560676 (each) 40195327560677, (case), Lot Numbers: DYNJ62015C;
REF DYNJ62015C: UDI/DI 10195327560676 (each) 40195327560677, (case), Lot Numbers: DYNJ62015C;
REF DYNJ62397C: UDI/DI 10195327401023 (each) 40195327401024, (case), Lot Numbers: DYNJ62397C;
REF DYNJ62611D: UDI/DI 10195327528164 (each) 40195327528165, (case), Lot Numbers: DYNJ62611D;
REF DYNJ62611D: UDI/DI 10195327528164 (each) 40195327528165, (case), Lot Numbers: DYNJ62611D;
REF DYNJ62611D: UDI/DI 10195327528164 (each) 40195327528165, (case), Lot Numbers: DYNJ62611D;
REF DYNJ63084C: UDI/DI 10195327505639 (each) 40195327505630, (case), Lot Numbers: DYNJ63084C;
REF DYNJ63084C: UDI/DI 10195327505639 (each) 40195327505630, (case), Lot Numbers: DYNJ63084C;
REF DYNJ63084C: UDI/DI 10195327505639 (each) 40195327505630, (case), Lot Numbers: DYNJ63084C;
REF DYNJ63285: UDI/DI 10193489733013 (each) 40193489733014, (case), Lot Numbers: DYNJ63285;
REF DYNJ63285A: UDI/DI 10198459104183 (each) 40198459104184, (case), Lot Numbers: DYNJ63285A;
REF DYNJ63405C: UDI/DI 10195327448431 (each) 40195327448432, (case), Lot Numbers: DYNJ63405C;
REF DYNJ63498C: UDI/DI 10195327510954 (each) 40195327510955, (case), Lot Numbers: DYNJ63498C;
REF DYNJ64238C: UDI/DI 10195327452322 (each) 40195327452323, (case), Lot Numbers: DYNJ64238C;
REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A;
REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A;
REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A;
REF DYNJ65242A: UDI/DI 10193489417074 (each) 40193489417075, (case), Lot Numbers: DYNJ65242A;
REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A;
REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A;
REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A;
REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A;
REF DYNJ65353A: UDI/DI 10195327232115 (each) 40195327232116, (case), Lot Numbers: DYNJ65353A;
REF DYNJ65362A: UDI/DI 10195327417772 (each) 40195327417773, (case), Lot Numbers: DYNJ65362A;
REF DYNJ65371A: UDI/DI 10195327417963 (each) 40195327417964, (case), Lot Numbers: DYNJ65371A;
REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B;
REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B;
REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B;
REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B;
REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B;
REF DYNJ65727B: UDI/DI 10195327528096 (each) 40195327528097, (case), Lot Numbers: DYNJ65727B;
REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B;
REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B;
REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B;
REF DYNJ67186B: UDI/DI 10195327299668 (each) 40195327299669, (case), Lot Numbers: DYNJ67186B;
REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B;
REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B;
REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B;
REF DYNJ67189B: UDI/DI 10195327299682 (each) 40195327299683, (case), Lot Numbers: DYNJ67189B;
REF DYNJ67540A: UDI/DI 10195327247591 (each) 40195327247592, (case), Lot Numbers: DYNJ67540A;
REF DYNJ67540A: UDI/DI 10195327247591 (each) 40195327247592, (case), Lot Numbers: DYNJ67540A;
REF DYNJ67540A: UDI/DI 10195327247591 (each) 40195327247592, (case), Lot Numbers: DYNJ67540A;
REF DYNJ69858: UDI/DI 10193489987102 (each) 40193489987103, (case), Lot Numbers: DYNJ69858;
REF DYNJ80171A: UDI/DI 10195327416775 (each) 40195327416776, (case), Lot Numbers: DYNJ80171A;
REF DYNJ80171A: UDI/DI 10195327416775 (each) 40195327416776, (case), Lot Numbers: DYNJ80171A;
REF DYNJ80171A: UDI/DI 10195327416775 (each) 40195327416776, (case), Lot Numbers: DYNJ80171A;
REF DYNJ81599: UDI/DI 10195327124021 (each) 40195327124022, (case), Lot Numbers: DYNJ81599;
REF DYNJ81599: UDI/DI 10195327124021 (each) 40195327124022, (case), Lot Numbers: DYNJ81599;
REF DYNJ81599: UDI/DI 10195327124021 (each) 40195327124022, (case), Lot Numbers: DYNJ81599;
REF DYNJ81602: UDI/DI 10195327123857 (each) 40195327123858, (case), Lot Numbers: DYNJ81602;
REF DYNJ81602: UDI/DI 10195327123857 (each) 40195327123858, (case), Lot Numbers: DYNJ81602;
REF DYNJ81602: UDI/DI 10195327123857 (each) 40195327123858, (case), Lot Numbers: DYNJ81602;
REF DYNJ81603: UDI/DI 10195327123864 (each) 40195327123865, (case), Lot Numbers: DYNJ81603;
REF DYNJ81603: UDI/DI 10195327123864 (each) 40195327123865, (case), Lot Numbers: DYNJ81603;
REF DYNJ81603: UDI/DI 10195327123864 (each) 40195327123865, (case), Lot Numbers: DYNJ81603;
REF DYNJ82871: UDI/DI 10195327212940 (each) 40195327212941, (case), Lot Numbers: DYNJ82871;
REF DYNJ82871: UDI/DI 10195327212940 (each) 40195327212941, (case), Lot Numbers: DYNJ82871;
REF DYNJ82871: UDI/DI 10195327212940 (each) 40195327212941, (case), Lot Numbers: DYNJ82871;
REF DYNJ84604: UDI/DI 10195327386061 (each) 40195327386062, (case), Lot Numbers: DYNJ84604;
REF DYNJ85113: UDI/DI 10195327460778 (each) 40195327460779, (case), Lot Numbers: DYNJ85113;
REF DYNJ85614: UDI/DI 10195327523794 (each) 40195327523795, (case), Lot Numbers: DYNJ85614;
REF DYNJ86151: UDI/DI 10195327598099 (each) 40195327598090, (case), Lot Numbers: DYNJ86151;
REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F;
REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F;
REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F;
REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F;
REF DYNJ900270F: UDI/DI 10195327348199 (each) 40195327348190, (case), Lot Numbers: DYNJ900270F;
REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G;
REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G;
REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G;
REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G;
REF DYNJ900271G: UDI/DI 10195327348137 (each) 40195327348138, (case), Lot Numbers: DYNJ900271G;
REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F;
REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F;
REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F;
REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F;
REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F;
REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F;
REF DYNJ900274F: UDI/DI 10195327487720 (each) 40195327487721, (case), Lot Numbers: DYNJ900274F;
REF DYNJ900709D: UDI/DI 10195327635312 (each) 40195327635313, (case), Lot Numbers: DYNJ900709D;
REF DYNJ900709D: UDI/DI 10195327635312 (each) 40195327635313, (case), Lot Numbers: DYNJ900709D;
REF DYNJ900710C: UDI/DI 10193489951325 (each) 40193489951326, (case), Lot Numbers: DYNJ900710C;
REF DYNJ900710D: UDI/DI 10195327635329 (each) 40195327635320, (case), Lot Numbers: DYNJ900710D;
REF DYNJ900710D: UDI/DI 10195327635329 (each) 40195327635320, (case), Lot Numbers: DYNJ900710D;
REF DYNJ900723C: UDI/DI 10193489951622 (each) 40193489951623, (case), Lot Numbers: DYNJ900723C;
REF DYNJ900723C: UDI/DI 10193489951622 (each) 40193489951623, (case), Lot Numbers: DYNJ900723C;
REF DYNJ900723C: UDI/DI 10193489951622 (each) 40193489951623, (case), Lot Numbers: DYNJ900723C;
REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D;
REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D;
REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D;
REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D;
REF DYNJ900723D: UDI/DI 10195327635343 (each) 40195327635344, (case), Lot Numbers: DYNJ900723D;
REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I;
REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I;
REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I;
REF DYNJ901652I: UDI/DI 10195327488123 (each) 40195327488124, (case), Lot Numbers: DYNJ901652I;
REF DYNJ904090D: UDI/DI 10193489282825 (each) 40193489282826, (case), Lot Numbers: DYNJ904090D;
REF DYNJ904090D: UDI/DI 10193489282825 (each) 40193489282826, (case), Lot Numbers: DYNJ904090D;
REF DYNJ904090D: UDI/DI 10193489282825 (each) 40193489282826, (case), Lot Numbers: DYNJ904090D;
REF DYNJ904306G: UDI/DI 10195327406370 (each) 40195327406371, (case), Lot Numbers: DYNJ904306G;
REF DYNJ904306G: UDI/DI 10195327406370 (each) 40195327406371, (case), Lot Numbers: DYNJ904306G;
REF DYNJ904699G: UDI/DI 10195327169299 (each) 40195327169290, (case), Lot Numbers: DYNJ904699G;
REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F;
REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F;
REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F;
REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F;
REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F;
REF DYNJ905071F: UDI/DI 10195327052386 (each) 40195327052387, (case), Lot Numbers: DYNJ905071F;
REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D;
REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D;
REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D;
REF DYNJ905565D: UDI/DI 10193489996180 (each) 40193489996181, (case), Lot Numbers: DYNJ905565D;
REF DYNJ906659F: UDI/DI 10193489999495 (each) 40193489999496, (case), Lot Numbers: DYNJ906659F;
REF DYNJ907612A: UDI/DI 10195327059132 (each) 40195327059133, (case), Lot Numbers: DYNJ907612A;
REF DYNJ907612A: UDI/DI 10195327059132 (each) 40195327059133, (case), Lot Numbers: DYNJ907612A;
REF DYNJ907614A: UDI/DI 10195327059149 (each) 40195327059140, (case), Lot Numbers: DYNJ907614A;
REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A;
REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A;
REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A;
REF DYNJ907615A: UDI/DI 10195327059156 (each) 40195327059157, (case), Lot Numbers: DYNJ907615A;
REF DYNJ908065A: UDI/DI 10195327125707 (each) 40195327125708, (case), Lot Numbers: DYNJ908065A;
REF DYNJ908065A: UDI/DI 10195327125707 (each) 40195327125708, (case), Lot Numbers: DYNJ908065A;
REF DYNJ908065A: UDI/DI 10195327125707 (each) 40195327125708, (case), Lot Numbers: DYNJ908065A;
REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A;
REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A;
REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A;
REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A;
REF DYNJ908643A: UDI/DI 10195327168414 (each) 40195327168415, (case), Lot Numbers: DYNJ908643A;
REF DYNJ909200: UDI/DI 10195327304034 (each) 40195327304035, (case), Lot Numbers: DYNJ909200;
REF DYNJ909570A: UDI/DI 10195327435530 (each) 40195327435531, (case), Lot Numbers: DYNJ909570A;
REF DYNJ909570B: UDI/DI 10198459176067 (each) 40198459176068, (case), Lot Numbers: DYNJ909570B;
REF DYNJVA900011D: UDI/DI 10195327550639 (each) 40195327550630, (case), Lot Numbers: DYNJVA900011D;
REF PHS397085007F: UDI/DI 10195327454128 (each) 40195327454129, (case), Lot Numbers: PHS397085007F;
REF PHS397101008F: UDI/DI 10195327454241 (each) 40195327454242, (case), Lot Numbers: PHS397101008F;
REF PHS397123008F: UDI/DI 10195327454135 (each) 40195327454136, (case), Lot Numbers: PHS397123008F. |
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
800-369-1704 |
|---|
Manufacturer Reason
for Recall | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2025 and 10/6/2025 via email and mail. The notice explained the issue with the component, potential risk, and requested the following actions:
1. Immediately check 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 found in the notice to complete the response form. Please list the quantity of affected product in inventory on the form. Even if no affected product is in inventory, please complete and submit the form.
3. Upon receipt of the submitted response form, the customer account will receive over-labels to place on affected inventory, with instructions for the customer staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
4. For distributors or those who 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. |
|---|
| Quantity in Commerce | 28679 kits |
|---|
| 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.
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