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High RiskFDA
Medline Industries, Lp
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: ...
Surgical Devices·14,927,765 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medical Devices·7,575 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES,...
Medical Devices·207,196 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have bee...
Medical Devices·125 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LI...
Medical Devices·9,720 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Pr...
Medical Devices·72,023 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Prod...
Medical Devices·93 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Cardiac Devices·551 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medical Devices·32 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP R...
Medical Devices·12,418 affected·Jan 7, 2026
High RiskFDA
Philips North America Llc
IQon Spectral CT; Product Code (REF): 728332;
Medical Devices·52 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: D...
Medical Devices·7,760 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT...
Diagnostic Devices·10,184 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, M...
Medical Devices·291 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Medical Devices·23,238 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: The...
Medical Devices·86,303 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Medical Devices·1,090 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Mod...
Medical Devices·12,529 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117...
Medical Implants·4,757 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT ...
Medical Devices·59 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Pro...
Medical Devices·5,946 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM...
Surgical Devices·553 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT...
Diagnostic Devices·7,494 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3)...
Medical Devices·1,056 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Pro...
Medical Devices·10,257 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3)...
Surgical Devices·3,561 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LA...
Medical Devices·29,192 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP200...
Surgical Devices·70,376,042 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been ...
Medical Devices·2,344 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LA...
Medical Devices·27,320 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM177...
Medical Devices·1,496 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: D...
Surgical Devices·193,157 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; ...
Medical Devices·5,346 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been ...
Medical Devices·650 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Cardiac Devices·599 affected·Jan 7, 2026
High RiskFDA
Karison Foods & Snacks, Inc.
Karison brand PANJIRI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Almonds, Sugar, Lotus Seeds, Fennel Seeds, Flax Seeds, Edible Gu...
Dairy·230 affected·Jan 6, 2026
High RiskFDA
Karison Foods & Snacks, Inc.
Karison brand BESAN LADDOO; NET WT. 12 oz.; Ingredients: Gram Flour, Butter, Sugar, Zero Trans Fat Vegetable Shortening, Almonds, Cardamo...
Dairy·230 affected·Jan 6, 2026
High RiskFDA
Karison Foods & Snacks, Inc.
Karison brand ALSI PINNI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Sugar Flax Seeds, Almonds, Zero Trans Fat, Vegetable Shorteni...
Dairy·230 affected·Jan 6, 2026
High RiskFDA
Encon Safety Products Co
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
Drugs·7,677 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·230,596 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·87,436 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·2,724 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·137,576 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·13,760 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·93,576 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·264,040 affected·Jan 6, 2026
High RiskFDA
Biomerieux Inc
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev...
Medical Devices·2,668,954 affected·Jan 5, 2026
High RiskFDA
Raz Design Inc
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotationa...
Medical Devices·66 affected·Jan 5, 2026