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15,654 recalls
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) 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) 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) 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) 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
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 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
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
RecallFDA
Straumann Usa Llc
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Medical Devices·561 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
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medical Devices·8,773 affected·Jan 5, 2026
High RiskFDA
Medline Industries, Lp
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOU...
Medical Devices·104,608 affected·Jan 5, 2026
High RiskFDA
Encore Medical, Lp
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Medical Devices·19 affected·Jan 5, 2026
High RiskFDA
Avid Medical, Inc.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Medical Devices·1,500 affected·Jan 2, 2026
High RiskFDA
Medline Industries, Lp
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ...
Medical Devices·926,227 affected·Dec 31, 2025
High RiskFDA
Medica Corporation
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Medical Devices·1,578 affected·Dec 31, 2025
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Medical Devices·47 affected·Dec 30, 2025
CriticalFDA
Whill, Inc.
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-whee...
Medical Devices·4,685 affected·Dec 29, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Medical Devices·41 affected·Dec 29, 2025
High RiskFDA
Cerapedics, Inc.
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Medical Devices·237 affected·Dec 29, 2025
CriticalFDA
Whill, Inc.
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel dri...
Medical Devices·2,324 affected·Dec 29, 2025
High RiskFDA
Cardinal Health 200, Llc
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardi...
Medical Devices·1,169,726 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTE...
Medical Devices·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) ...
Medical Devices·0 affected·Dec 26, 2025
High RiskFDA
Medline Industries, Lp
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SW...
Medical Devices·7,380 affected·Dec 24, 2025
High RiskFDA
Zimmer Surgical Inc
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Versi...
Medical Devices·51 affected·Dec 24, 2025
High RiskFDA
Medline Industries, Lp
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medical Devices·450 affected·Dec 24, 2025
High RiskFDA
Zimmer Surgical Inc
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Versi...
Medical Devices·206 affected·Dec 24, 2025
High RiskFDA
Focalyx Technologies, Llc.
Focalyx Fusion
Medical Devices·18 affected·Dec 23, 2025
High RiskFDA
Lsl Healthcare Inc.
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Medical Devices·1,400 affected·Dec 22, 2025