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High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been ...
Medical Devices·1,025 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS9854...
Medical Devices·7,725 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have bee...
Medical Devices·7,689 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TR...
Medical Devices·753 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Mode...
Medical Devices·15,806 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have bee...
Medical Devices·1,072 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-0725; Software Version: N/A Pro...
Medical Devices·1,474 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have bee...
Medical Devices·887 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Nu...
Medical Devices·114,778 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL ...
Medical Devices·6,676 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-0720; Software Version: N/A Pro...
Medical Devices·10,008 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; 3)...
Medical Devices·5,562 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) M...
Diagnostic Devices·82,597 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: The...
Medical Devices·30,489 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
Medline Industries, Lp
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCO...
Medical Devices·175 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medical Devices·108 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) ...
Medical Devices·753 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS9...
Medical Devices·9,051 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Medical Devices·808 affected·Jan 7, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC A...
Surgical Devices·6,961 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-VC431Q-0730; Software Version: N/A Pr...
Medical Devices·4,183 affected·Jan 7, 2026
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