HIGHFDA DRUGBusulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.May 4, 2026BUSULFANFailed Impurities/DegradationRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU...May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI,...May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEPediatric care bed; Product Designation: KayserBett IDA;May 4, 2026KAYSERBETTEN GMBH & CO. KGIf theRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378AMay 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW...May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16CMay 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253AMay 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO,...May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit...May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the...May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; ...May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407May 4, 2026Medline Industries, LPDuring anRead more
HIGHFDA DEVICEMEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)May 4, 2026Medline Industries, LPDuring anRead more