Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 recalls
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 79 of 810
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC0…
MEDLINE INDUSTRIES, LP - Northfield
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Boston Scientific Corporation
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Instrumentation Laboratory
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, n…
Alphatec Spine, Inc.
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERI…
MEDLINE INDUSTRIES, LP - Northfield
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for …
B. Braun Medical, Inc.
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Karl Storz Endoscopy
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Boston Scientific Corporation
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Zimmer, Inc.
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Boston Scientific Corporation
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Boston Scientific Corporation
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The Liv…
LivaNova USA, Inc.
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
MEDLINE INDUSTRIES, LP - Northfield
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Murata Vios, Inc.
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Descript…
LivaNova USA, Inc.
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Boston Scientific Corporation
AliExpress Recalls Multi Styler Hair Dryers Due to Electrocution or Shock Hazards; Sold on AliExpress.com
Super Appliance Store, of China
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 C…
Percussionaire Corporation
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model N…
Olympus Corporation of the Americas
BD Pyxis Med ES Auxiliary (AUX), REF 343
CareFusion 303, Inc.
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Adept Medical Ltd
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Stryker Corporation
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A…
Trinity Sterile, Inc.
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…
Olympus Corporation of the Americas
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Stryker Corporation
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model …
Olympus Corporation of the Americas
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Adept Medical Ltd
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Baxter Healthcare Corporation
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…
Olympus Corporation of the Americas
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy…
Stryker Corporation
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
MICROVENTION INC.
BD PCR Cartridges used with MAX System. Model Number: 437519
Becton Dickinson & Co.
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medtronic Perfusion Systems
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Compone…
O&M HALYARD, INC.
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A P…
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number…
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF…
Trinity Sterile, Inc.
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Softwa…
Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China…
Ortho-Clinical Diagnostics, INc.
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Adept Medical Ltd
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…
Olympus Corporation of the Americas
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 …
Ortho-Clinical Diagnostics, INc.
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…
Olympus Corporation of the Americas
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 Jun 3, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jun 3, 2026.