Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 260 of 819
Senior Living Arial Emergency and Nurse Call Systems
Stanley Security Solutions Inc
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Philips North America Llc
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Draeger Medical, Inc.
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Ortho-Clinical Diagnostics, Inc.
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Microbiologics Inc
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # …
Siemens Medical Solutions USA, Inc
Heel Snuggler, Reference # 989805603411 99047
Philips North America Llc
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Gentueri Inc
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Straumann USA LLC
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Luminex Corporation
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Straumann USA LLC
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Philips North America Llc
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Philips North America Llc
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagno…
Konica Minolta Healthcare Americas, Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) C…
ev3 Inc.
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 81…
Compass Health Brands (Corporate Office)
SOMATOM Edge Plus-Computed tomography system Model 1026700
Siemens Medical Solutions USA, Inc
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model B…
Medtronic Perfusion Systems
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
DePuy Orthopaedics, Inc.
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Technomed Europe
SOMATOM Definition AS-Computed tomography system Model 8098027
Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge -Computed tomography system Model 10590000
Siemens Medical Solutions USA, Inc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recover…
Philips North America Llc
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Gentherm Medical, LLC
Regard, T AND A - Rogers, sterilized convenience kits
ROi CPS LLC
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement …
Ohio Medical Corporation
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
DePuy Orthopaedics, Inc.
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Haag-Streit USA Inc
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Ion Beam Applications S.A.
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
DePuy Orthopaedics, Inc.
SOMATOM Confidence -Computed tomography systems Model 10590100
Siemens Medical Solutions USA, Inc
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Canon Medical System, USA, INC.
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
PTW NORTH AMERICA CORPORATION
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Covidien Llc
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment P…
Reflexion Medical, Inc.
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 68…
Getinge Usa Sales Inc
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Haag-Streit USA Inc
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
DePuy Orthopaedics, Inc.
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002,…
Philips North America Llc
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
DePuy Orthopaedics, Inc.
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for m…
Ki Mobility Llc
GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
DePuy Orthopaedics, Inc.
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Qiagen Sciences LLC
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IF…
Invacare Corporation
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medshape, INC.
DBB-06 Hemodialysis Delivery System
Nikkiso Ltd - Shizuoka Plant
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Uromedica Inc.
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instrument…
Howmedica Osteonics Corp.
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 29, 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 29, 2026.