Class 2 Device Recall Medline

• Date Initiated by Firm: February 11, 2025
• Date Posted: March 25, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1444-2025
• Recall Event ID: 96374
• 510(K)Number: K962826
• Product Classification: General surgery tray - Product Code LRO
• Product: Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A; 12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A; 13) CABG PACK, Pack Number DYNJ20114Q; 14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L; 15) CHEST PACK SC-LF, Pack Number DYNJ38051F; 16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B; 17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B; 18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C; 19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B; 20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385; 21) CT BASIC PACK, Pack Number DYNJ51617A; 22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I; 23) CYSTO, Pack Number DYNJ24351D; 24) CYSTO PACK, Pack Number DYNJ62359A; 25) DAVINCI PACK, Pack Number DYNJ04113C; 26) DUPYTRENS PACK, Pack Number DYNJ60496; 27) EH PACEMAKER PACK, Pack Number DYNJ55734C; 28) EVLT PACK, Pack Number DYNJ45997C; 29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G; 30) GENERAL BASIC PACK, Pack Number DYNJ82039; 31) GENERAL PURPOSE CV, Pack Number DYNJ904395F; 32) GENERAL UTILITY PACK, Pack Number DYNJ45093B; 33) HP DEVICE-LF, Pack Number DYNJ62255A; 34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B; 35) IR PACK, Pack Number DYNJ32080L; 36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857; 37) IR TABLE PACK II, Pack Number DYNJ56298B; 38) JVL-PACK TUNNELED, Pack Number DYNJ66065; 39) LITHOTOMY PACK, Pack Number DYNJ66490B; 40) LITHOTOMY PACK, Pack Number DYNJ65380A; 41) LOOP RECORDER PACK, Pack Number DYNJ53221B; 42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A; 43) MAJOR BASIN PACK, Pack Number DYNJ67484A; 44) MAJOR PACK, Pack Number DYNJ51996; 45) MAJOR PACK-LF, Pack Number DYNJ24599I; 46) MINI PACK, Pack Number DYNJ52305D; 47) MINI SET UP KIT, Pack Number DYNJ81562; 48) MINOR BASIN, Pack Number DYNJ43021B; 49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286; 50) MINOR PACK-LF, Pack Number DYNJ0551383P; 51) MINOR PK-LF, Pack Number DYNJ21408D; 52) MINOR WAKEFIELD, Pack Number DYNJ58872A; 53) MYELOGRAM TRAY, Pack Number DYNDH1775A; 54) OB PACK, Pack Number DYNJ32216B; 55) OPEN STERILE PACK, Pack Number DYNJ62104A; 56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B; 57) PACK URO-BASIC, Pack Number DYNJ38246A; 58) PACK,LTD BODY SSP, Pack Number DYNJ65488B; 59) PARACENTESIS, Pack Number DYNJ44505B; 60) PBMS NECK PACK-LF, Pack Number DYNJ64961A; 61) PEDI MAJOR PACK, Pack Number DYNJ40062K; 62) PEDI PK-LF, Pack Number DYNJ21240J; 63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B; 64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B; 65) PK, GEN-MINOR, Pack Number DYNJ59461C; 66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B; 67) PK, URO-CYSTO-MH, Pack Number DYNJ62501; 68) PK-GEN-BASIC, Pack Number DYNJ42382B; 69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B; 70) PODIATRY PACK, Pack Number DYNJ37297D; 71) PST PACK, Pack Number DYNJ62666; 72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J; 73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A; 74) SHUNT PACK-LF, Pack Number PHS967363W; 75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242; 76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X; 77) STANDARD ICL PACK-LF, Pack Number PHS895675B; 78) T & A PK-LF, Pack Number DYNJT2408C; 79) THORACIC PACK SHD, Pack Number DYNJ68416C; 80) TONSIL PACK-LF, Pack Number DYNJ0553334I; 81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I; 82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M; 83) VASECTOMY PACK, Pack Number DYNJ65326; 84) VASECTOMY PACK,
• Code Information: 1) Pack Number DYNJHS0136D: UDI/DI 10889942848973 (each) 40889942848974 (case), Lot Number 22JBC557Z; 2) Pack Number DYNJ56987B: UDI/DI 10889942868193 (each) 40889942868194 (case), Lot Number 21EBN072A; 3) Pack Number PHS170994005A: UDI/DI 10888277754379 (each) 40888277754370 (case), Lot Number 21IMG402A; 4) Pack Number DYNJ54836B: UDI/DI 10193489574128 (each) 40193489574129 (case), Lot Number 21BBH689A; 5) Pack Number DYNJ58678A: UDI/DI 10888277781207 (each) 40888277781208 (case), Lot Number 21GMF677A; 6) Pack Number DYNJ63532: UDI/DI 10193489748468 (each) 40193489748469 (case), Lot Number 22CMB574A; 7) Pack Number DYNJ81702: UDI/DI 10195327135447 (each) 40195327135448 (case), Lot Number 23CBF695A; 8) Pack Number DYNJ36595D: UDI/DI 10193489928976 (each) 40193489928977 (case), Lot Number 23CBL653A; 9) Pack Number DYNJ69250A: UDI/DI 10195327142315 (each) 40195327142316 (case), Lot Number 23HME051A; 10) Pack Number DYNJ50470C: UDI/DI 10889942922611 (each) 40889942922612 (case), Lot Number 23FME520A; 11) Pack Number DYNJ0115839A: UDI/DI 10193489901764 (each) 40193489901765 (case), Lot Number 23FME450A; 12) Pack Number PHS396134006A: UDI/DI 10889942694303 (each) 40889942694304 (case), Lot Number 23DDA331A; 13) Pack Number DYNJ20114Q: UDI/DI 10193489549249 (each) 40193489549240 (case), Lot Number 22JBF822Z; 14) Pack Number DYNJ0375705L: UDI/DI 10193489544138 (each) 40193489544139 (case), Lot Number 22GBP901M; 15) Pack Number DYNJ38051F: UDI/DI 10193489909319 (each) 40193489909310 (case), Lot Number 23EMC825A; 16) Pack Number DYNJ0161358B: UDI/DI 10889942213269 (each) 40889942213260 (case), Lot Number 23DDA354A; 17) Pack Number DYNJ50844B: UDI/DI 10889942883271 (each) 40889942883272 (case), Lot Number 22GMD340Z; 18) Pack Number DYNJ46776C: UDI/DI 10889942893218 (each) 40889942893219 (case), Lot Number 21BBE822A; 19) Pack Number DYNJ40640B: UDI/DI 10193489292145 (each) 40193489292146 (case), Lot Number 21IME326A; 20) Pack Number DYNJ39385: UDI/DI 10884389765067 (each) 40884389765068 (case), Lot Number 21IMD121A; 21) Pack Number DYNJ51617A: UDI/DI 10889942448616 (each) 40889942448617 (case), Lot Number 20LKB440A; 22) Pack Number DYNJ06672I: UDI/DI 10889942725830 (each) 40889942725831 (case), Lot Number 23BBU700A; 23) Pack Number DYNJ24351D: UDI/DI 10193489738841 (each) 40193489738842 (case), Lot Number 21LBD180A; 24) Pack Number DYNJ62359A: UDI/DI 10193489202571 (each) 40193489202572 (case), Lot Number 20AKB925A; 25) Pack Number DYNJ04113C: UDI/DI 10889942934102 (each) 40889942934103 (case), Lot Number 21EBP303A; 26) Pack Number DYNJ60496: UDI/DI 10193489506174 (each) 40193489506175 (case), Lot Number 22GBU071Z; 27) Pack Number DYNJ55734C: UDI/DI 10889942779093 (each) 40889942779094 (case), Lot Number 20FMA632A; 28) Pack Number DYNJ45997C: UDI/DI 10889942684366 (each) 40889942684367 (case), Lot Number 23GBF502A; 29) Pack Number DYNJ51799G: UDI/DI 10193489475944 (each) 40193489475945 (case), Lot Number 22CDB465A; 30) Pack Number DYNJ82039: UDI/DI 10195327163877 (each) 40195327163878 (case), Lot Number 23EBE702A; 31) Pack Number DYNJ904395F: UDI/DI 10193489701333 (each) 40193489701334 (case), Lot Number 22FBS141Z; 32) Pack Number DYNJ45093B: UDI/DI 10195327044213 (each) 40195327044214 (case), Lot Number 23BLB075A; 33) Pack Number DYNJ62255A: UDI/DI 10193489276671 (each) 40193489276672 (case), Lot Number 22GBU775A; 34) Pack Number DYNJ42231B: UDI/DI 10193489948165 (each) 40193489948166 (case), Lot Number 21HMB550A; 35) Pack Number DYNJ32080L: UDI/DI 10193489691900 (each) 40193489691901 (case), Lot Number 21BBJ386A; 36) Pack Number DYNJ64857: UDI/DI 10193489223361 (each) 40193489223362 (case), Lot Number 21IME211A; 37) Pack Number DYNJ56298B: UDI/DI 10193489415902 (each) 40193489415903 (case), Lot Number 21HME360A; 38) Pack Number DYNJ66065: UDI/DI 10193489319187 (each) 40193489319188 (case), Lot Number 23LMG850A; 39) Pack Number DYNJ66490B: UDI/DI 10195327472962 (each) 40195327472963 (case), Lot Number 23HMC391A; 40) Pack Number DYNJ65380A: UDI/DI 10195327418083 (each) 40195327418084 (case), Lot Number 23LMF918A; 41) Pack Number DYNJ53221B: UDI/DI 10193489922288 (each) 40193489922289 (case), Lot Number 23GMC211A; 42) Pack Number DYNJ48058A: UDI/DI 10193489325669 (each) 40193489325660 (case), Lot Number 21JMH979A; 43) Pack Number DYNJ67484A: UDI/DI 10195327020743 (each) 40195327020744 (case), Lot Number 23DME735A; 44) Pack Number DYNJ51996: UDI/DI 10889942233205 (each) 40889942233206 (case), Lot Number 21BBG178A; 45) Pack Number DYNJ24599I: UDI/DI 10193489315141 (each) 40193489315142 (case), Lot Number 21IMH674A; 46) Pack Number DYNJ52305D: UDI/DI 10195327028572 (each) 40195327028573 (case), Lot Number 22JBU974A; 47) Pack Number DYNJ81562: UDI/DI 10195327122539 (each) 40195327122530 (case), Lot Number 22JBW597A; 48) Pack Number DYNJ43021B: UDI/DI 10193489258851 (each) 40193489258852 (case), Lot Number 21GMC689A; 49) Pack Number DYNJ69286: UDI/DI 10193489922189 (each) 40193489922180 (case), Lot Number 23IMF699A; 50) Pack Number DYNJ0551383P: UDI/DI 10889942962143 (each) 40889942962144 (case), Lot Number 21GMB523A; 51) Pack Number DYNJ21408D: UDI/DI 10195327053642 (each) 40195327053643 (case), Lot Number 21LMF738A; 52) Pack Number DYNJ58872A: UDI/DI 10193489751871 (each) 40193489751872 (case), Lot Number 23JBW564A; 53) Pack Number DYNDH1775A: UDI/DI 10195327362218 (each) 40195327362219 (case), Lot Number 23LBM803Z; 54) Pack Number DYNJ32216B: UDI/DI 10193489546101 (each) 40193489546102 (case), Lot Number 21BBF074A; 55) Pack Number DYNJ62104A: UDI/DI 10193489763713 (each) 40193489763714 (case), Lot Number 23FBO390A; 56) Pack Number DYNJ60124B: UDI/DI 10193489982855 (each) 40193489982856 (case), Lot Number 21LMG031A; 57) Pack Number DYNJ38246A: UDI/DI 10884389757772 (each) 40884389757773 (case), Lot Number 23BBQ828A; 58) Pack Number DYNJ65488B: UDI/DI 10193489443646 (each) 40193489443647 (case), Lot Number 23LMG039A; 59) Pack Number DYNJ44505B: UDI/DI 10889942379248 (each) 40889942379249 (case), Lot Number 20BDB430A; 60) Pack Number DYNJ64961A: UDI/DI 10193489416039 (each) 40193489416030 (case), Lot Number 23IMF244A; 61) Pack Number DYNJ40062K: UDI/DI 10195327493325 (each) 40195327493326 (case), Lot Number 23LMF453A; 62) Pack Number DYNJ21240J: UDI/DI 10889942931378 (each) 40889942931379 (case), Lot Number 21IMH809A; 63) Pack Number DYNJ51725B: UDI/DI 10193489538731 (each) 40193489538732 (case), Lot Number 21KBJ357A; 64) Pack Number DYNJ55355B: UDI/DI 10195327173784 (each) 40195327173785 (case), Lot Number 23CBN280A; 65) Pack Number DYNJ59461C: UDI/DI 10195327510107 (each) 40195327510108 (case), Lot Number 24ABA333Z; 66) Pack Number DYNJ43754B: UDI/DI 10193489808964 (each) 40193489808965 (case), Lot Number 20HMD448A; 67) Pack Number DYNJ62501: UDI/DI 10193489664829 (each) 40193489664820 (case), Lot Number 21LBB961A; 68) Pack Number DYNJ42382B: UDI/DI 10195327253288 (each) 40195327253289 (case), Lot Number 23LMG144A; 69) Pack Number DYNJ41824B: UDI/DI 10889942933488 (each) 40889942933489 (case), Lot Number 21LBW098A; 70) Pack Number DYNJ37297D: UDI/DI 10193489566567 (each) 40193489566568 (case), Lot Number 21JMH963A; 71) Pack Number DYNJ62666: UDI/DI 10193489679663 (each) 40193489679664 (case), Lot Number 23BBR333A; 72) Pack Number DYNJ0785683J: UDI/DI 10193489709315 (each) 40193489709316 (case), Lot Number 23LMD781A; 73) Pack Number DYNJ43502A: UDI/DI 10193489767858 (each) 40193489767859 (case), Lot Number 21BBI542A; 74) Pack Number PHS967363W: UDI/DI 10889942924561 (each) 40889942924562 (case), Lot Number 21LME249A; 75) Pack Number DYNJ30242: UDI/DI 10080196785834 (each) 40080196785835 (case), Lot Number 23LMG145A; 76) Pack Number DYNJ0129513X: UDI/DI 10195327511876 (each) 40195327511877 (case), Lot Number 23LMG678A; 77) Pack Number PHS895675B: UDI/DI 10193489418316 (each) 40193489418317 (case), Lot Number 22IMB409A; 78) Pack Number DYNJT2408C: UDI/DI 10884389367643 (each) 40884389367644 (case), Lot Number 21AMA394A; 79) Pack Number DYNJ68416C: UDI/DI 10195327341688 (each) 40195327341689 (case), Lot Number 23LBS810Z; 80) Pack Number DYNJ0553334I: UDI/DI 10193489513646 (each) 40193489513647 (case), Lot Number 23HME093A; 81) Pack Number DYNJ0375928I: UDI/DI 10193489544220 (each) 40193489544221 (case), Lot Number 23CBB970A; 82) Pack Number DYNJ0416615M: UDI/DI 10195327518936 (each) 40195327518937 (case), Lot Number 24DMC685Z; 83) Pack Number DYNJ65326: UDI/DI 10193489267587 (each) 40193489267588 (case), Lot Number 21LBG918A; 84) Pack Number DYNJ84729: UDI/DI 10195327407247 (each) 40195327407248 (case), Lot Number 23GBV524A; 85) Pack Number DYNJ57459A: UDI/DI 10888277759596 (each) 40888277759597 (case), Lot Number 22GBE165A; 86) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case), Lot Number 22GDB223A; 87) Pack Number LINQKIT: 10193489709827 (each) 40193489709828 (case), Lot Number 23EDA439A
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583
• Quantity in Commerce: 11,363 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = LRO