Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- 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 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 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 80 of 808
Bodor P and C series laser cutting machines
Jinan Bodor Cnc Machine Co Ltd
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
CareFusion 303, Inc.
BD Pyxis MedStation ES (Med ES Main), REF 323
CareFusion 303, Inc.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pre…
Integra LifeSciences Corp.
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Randox Laboratories, Limited
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Baxter Healthcare Corporation
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Baxter Healthcare Corporation
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Adept Medical Ltd
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Medtronic Perfusion Systems
BD Pyxis MedStation 4000 AUX, REF 306
CareFusion 303, 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
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model …
Olympus Corporation of the Americas
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description:…
Trinity Sterile, Inc.
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN)…
St. Jude Medical
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
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) …
St. Jude Medical
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tam…
Integrity Implants Inc.
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pre…
Integra LifeSciences Corp.
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Medtronic Perfusion Systems
BD Pyxis MedStation ES AUX, REF 324
CareFusion 303, Inc.
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Adept Medical Ltd
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular …
Integra LifeSciences Corp.
SHEIN Distribution Corporation Recalls Teckwe Hair Dryer Brushes Due to Electrocution or Shock Hazard
SHEIN Distribution Corporation, of Los Angeles, California
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model N…
Boston Scientific Corporation
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Baxter Healthcare Corporation
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-…
Augustine Temperature Management, LLC
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Intuitive Surgical, Inc.
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB632…
Coloplast Manufacturing US, LLC
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Intuitive Surgical, Inc.
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DIL…
Sklar Instruments
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Intuitive Surgical, Inc.
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAU…
Sklar Instruments
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the inst…
Olympus Corporation of the Americas
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Cook Biotech, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic, Inc.
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refu…
Augustine Temperature Management, LLC
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
SIN SISTEMA DE IMPLANTE NACIONAL S.A
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Sklar Instruments
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Intuitive Surgical, Inc.
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP…
Sklar Instruments
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Intuitive Surgical, Inc.
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNED…
MEDLINE INDUSTRIES, LP - Northfield
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Intuitive Surgical, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Abiomed, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Intuitive Surgical, Inc.
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquade…
Nuwellis Inc
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK …
Cardinal Health 200, LLC
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 Jul 2, 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 Jul 2, 2026.