Product category · Updated Mar 18, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Category snapshot
Medical Devices accounts for 27,372 recalls — about 32.6% of the 83,949-record federal archive, with 2,343 graded high-severity, most issued by FDA Devices.
- 27,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 2,343
High severity
2,343 recalls
- Moderate
Moderate
24,310 recalls
- Lower severity 719
Lower severity
719 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
26,000 recalls
- FDA Drug 880
FDA Drug
880 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 51
FDA Food
51 recalls
Recalls in Medical Devices
Newest first · Page 5 of 548
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Descri…
Olympus Corporation of the Americas
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Boston Scientific Corporation
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Vortex Surgical Inc.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed t…
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 Product Descri…
Olympus Corporation of the Americas
Vortex Surgical I2 Injection Kit, VS0500
Vortex Surgical Inc.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Descript…
Olympus Corporation of the Americas
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Vortex Surgical Inc.
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instrumen…
Olympus Corporation of the Americas
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Encore Medical, LP
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; …
Changchun Wancheng Bio-Electron Co., Ltd.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Descrip…
Olympus Corporation of the Americas
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Boston Scientific Corporation
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product …
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 Product Descrip…
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 designed to …
Olympus Corporation of the Americas
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
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
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.
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
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Am…
Fujirebio Diagnostics, Inc.
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.
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.
S. Typhi/Para Typhi A Antigen
Changchun Wancheng Bio-Electron Co., Ltd.
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Vortex Surgical Inc.
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
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
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product …
Fujirebio Diagnostics, Inc.
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Tornier, Inc
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
LSL Healthcare Inc.
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
AlternatiV+ Screw-In Anchor
Aju Pharm Co., Ltd.
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medline Industries, LP
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Philips North America
Genesis Push-In Suture Anchor
Aju Pharm Co., Ltd.
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Philips North America
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Siemens Medical Solutions USA, Inc
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Produc…
SunMed Holdings, LLC
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
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
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Philips North America
BEAR Implant. Model Number: 1000.
Miach Orthopaedics
Fixone Biocomposite Anchor
Aju Pharm Co., Ltd.
Fixone Hybrid Anchor
Aju Pharm Co., Ltd.
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
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices — browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA — openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls
- Source: NHTSA — National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Mar 18, 2026.
Read our methodology — how this data is sourced, computed, and verified.
