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 23 of 810
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
ICU Medical, Inc.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
ICU Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
ICU Medical, Inc.
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor in…
Edan Diagnostics
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni…
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
Medline Industries, LP
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting i…
Community Products, LLC
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation…
RAYSEARCH LABORATORIES AB
Merit Medical , Custom Manifold Kit REF: K09-13203A
Merit Medical Systems, Inc.
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Merit Medical Systems, Inc.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A,…
RAYSEARCH LABORATORIES AB
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.69…
Tyber Medical
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the si…
Community Products, LLC
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform l…
Edan Diagnostics
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2,…
RAYSEARCH LABORATORIES AB
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and …
Edan Diagnostics
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MH…
LEASEIR TECHNOLOGIES SLU
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Baxter Healthcare Corporation
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Medline Industries, LP
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C…
Merit Medical Systems, Inc.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring …
Edan Diagnostics
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
ICU Medical, Inc.
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Medline Industries, LP
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Ra…
RAYSEARCH LABORATORIES AB
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Merit Medical Systems, Inc.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital sign…
Edan Diagnostics
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description…
MicroPort Orthopedics Inc.
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Sysmex America, Inc.
Allwell Angioplasty Pack REF: IS-30-B1/B
Merit Medical Systems, Inc.
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system…
Edan Diagnostics
Patient Information Center iX; Software Version Number: 4.5.0
Philips North America
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter…
Edan Diagnostics
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.68…
Tyber Medical
Mazor X robotic guidance system REF: TPL0059
Mazor Robotics Ltd
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein part…
Beckman Coulter Ireland, Inc.
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The…
Intuitive Surgical, Inc.
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
RAYSEARCH LABORATORIES AB
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are …
Edan Diagnostics
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or as…
Community Products, LLC
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor inc…
Edan Diagnostics
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4
Medline Industries, LP
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called…
Edan Diagnostics
SQ40S Blood Transfusion Filter
GVS TM, Inc
Thrasio Recalls Angry Orange Enzyme Stain Removers Due to Risk of Exposure to Bacteria
Thrasio, LLC, of Boston, Massachusetts
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Elekta, Inc.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Canon Medical System, USA, INC.
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Medline Industries, LP
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Intuitive Surgical, Inc.
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
Allura Xper FD10F; Model Number: 722002;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.