Recall Z-1399-2026

Medline Industries, LP · initiated January 7, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146C; 59) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146D; 60) KIT THORACIC THYMECTOMY, Model Number: DYKMBNDL161; 61) KIT ORTHO TOTAL SHOULDER, Model Number: DYKMBNDL162B; 62) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165B; 63) KIT OMF MINOR, Model Number: DYKMBNDL166; 64) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167; 65) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167A; 66) KIT TRANSPLANT LIVER EX-LAP, Model Number: DYKMBNDL167B; 67) KIT LAP DONOR NEPHRECTOMY, Model

Codes / lots: 1) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973; 2) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22BDB172; 3) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21LDA438; 4) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB692; 5) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB175; 6) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24GDA256; 7) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23IDB293; 8) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDC028; 9) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDB192; 10) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDA657; 11) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22LDA361; 12) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22KDB086; 13) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22JDB707; 14) ACC010475, UDI-DI: 10193489469011(each)…

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: Under Investigation by firm

Action taken

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,

Details

Recall number
Z-1399-2026
Initiated
January 7, 2026
Posted by FDA
February 17, 2026
Product code
LRO – General Surgery Tray
Quantity
154427 units
Distribution
Worldwide distribution - US Nationwide.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1384-2026 Class IIMedline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1385-2026 Class IIMedline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1386-2026 Class IIMedline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1387-2026 Class IIMedline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150CMedline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1388-2026 Class IIMedline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1389-2026 Class IIMedline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1390-2026 Class IIMedline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1391-2026 Class IIMedline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1392-2026 Class IIMedline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1393-2026 Class IIMedline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1394-2026 Class IIMedline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1395-2026 Class IIMedline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1396-2026 Class IIMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1397-2026 Class IIMedline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1398-2026 Class IIMedline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1400-2026 Class IIMedline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1401-2026 Class IIMedline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1402-2026 Class IIMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1403-2026 Class IIMedline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806LMedline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1404-2026 Class IIMedline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1405-2026 Class IIMedline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200AMedline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1406-2026 Class IIMedline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118AMedline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1407-2026 Class IIMedline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031AMedline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1408-2026 Class IIMedline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945PMedline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1409-2026 Class IIMedline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1410-2026 Class IIMedline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMedline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1411-2026 Class IIMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1412-2026 Class IIMedline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1413-2026 Class IIMedline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified
Z-1414-2026 Class IIMedline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… 01/07/2026Open, Classified