FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 2 of 520
Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to …
Olympus Corporation of the Americas
Moderate Feb 11, 2026
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
Moderate Feb 11, 2026
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Pr…
Olympus Corporation of the Americas
Moderate Feb 11, 2026
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: L…
Fujirebio Diagnostics, Inc.
Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to …
Olympus Corporation of the Americas
Moderate Feb 11, 2026
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Am…
Fujirebio Diagnostics, Inc.
Moderate Feb 11, 2026
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exenda…
Vortex Surgical Inc.
Moderate Feb 11, 2026
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by p…
Medtronic MiniMed, Inc.
Moderate Feb 11, 2026
S. Typhi/Para Typhi A Antigen
Changchun Wancheng Bio-Electron Co., Ltd.
Moderate Feb 11, 2026
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Vortex Surgical Inc.
Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instrumen…
Olympus Corporation of the Americas
Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Descrip…
Olympus Corporation of the Americas
Moderate Feb 11, 2026
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product …
Fujirebio Diagnostics, Inc.
Moderate Feb 11, 2026
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Tornier, Inc
Moderate Feb 4, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
LSL Healthcare Inc.
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X…
Medline Industries, LP
Moderate Feb 4, 2026
AlternatiV+ Screw-In Anchor
Aju Pharm Co., Ltd.
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medline Industries, LP
Moderate Feb 4, 2026
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
Genesis Push-In Suture Anchor
Aju Pharm Co., Ltd.
Moderate Feb 4, 2026
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Siemens Medical Solutions USA, Inc
Critical Feb 4, 2026
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Produc…
SunMed Holdings, LLC
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ4564…
Medline Industries, LP
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU D…
Medline Industries, LP
Moderate Feb 4, 2026
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
BEAR Implant. Model Number: 1000.
Miach Orthopaedics
Moderate Feb 4, 2026
Fixone Biocomposite Anchor
Aju Pharm Co., Ltd.
Moderate Feb 4, 2026
Fixone Hybrid Anchor
Aju Pharm Co., Ltd.
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU …
Medline Industries, LP
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medline Industries, LP
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR…
Medline Industries, LP
Moderate Feb 4, 2026
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software…
Zimmer Surgical Inc
Moderate Feb 4, 2026
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health S…
Cardinal Health 200, LLC
Moderate Feb 4, 2026
Genesis Knotless Anchor
Aju Pharm Co., Ltd.
Moderate Feb 4, 2026
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWA…
GOLD STAR DISTRIBUTION INC
Moderate Feb 4, 2026
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Cerapedics, Inc.
Moderate Feb 4, 2026
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; …
GOLD STAR DISTRIBUTION INC
Moderate Feb 4, 2026
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3)…
Medline Industries, LP
Moderate Feb 4, 2026
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Canon Medical System, USA, INC.
Moderate Feb 4, 2026
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software…
Zimmer Surgical Inc
Moderate Feb 4, 2026
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT70…
Medline Industries, LP
Moderate Feb 4, 2026
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; …
Medline Industries, LP