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 348 of 819
REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016842
ICU Medical, Inc.
Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultr…
Philips Ultrasound Inc
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replaceme…
Maquet Cardiovascular, LLC
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Howmedica Osteonics Corp.
Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.…
Inpeco S.A.
Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Us…
Nobel Biocare Usa Llc
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT…
WELCH ALLYN, INC/MORTARA
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemost…
Boston Scientific Corporation
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoro…
Philips North America, LLC
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Con…
WELCH ALLYN, INC/MORTARA
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE I…
WELCH ALLYN, INC/MORTARA
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro …
Uromedica Inc.
Lunar iDXA bone densitometer
GE Healthcare, LLC
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
GE Healthcare, LLC
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil)…
Stryker Instruments Div. of Stryker Corporation
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Viewray, Inc.
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the followin…
WELCH ALLYN, INC/MORTARA
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Merit Medical Systems, Inc.
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is i…
U&I CORP.
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Elekta Inc
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Boston Scientific Corporation
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Produc…
Stryker Sustainability Solutions
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Siemens Healthcare Diagnostics, Inc.
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) …
Becton Dickinson & Company
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data …
WELCH ALLYN, INC/MORTARA
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is…
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used …
Obalon Therapeutics Inc
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Vascular Solutions, Inc.
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Avanos Medical, Inc.
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
WELCH ALLYN, INC/MORTARA
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Philips North America, LLC
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System…
Beckman Coulter Inc.
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
GE Healthcare, LLC
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Ortho Clinical Diagnostics
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients…
Elekta Inc
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ec…
WELCH ALLYN, INC/MORTARA
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedur…
Philips North America, LLC
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Wa…
WELCH ALLYN, INC/MORTARA
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
GE Healthcare, LLC
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the d…
Bio-Rad Labs
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is A…
Allied Vision Group Inc
S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNA…
WELCH ALLYN, INC/MORTARA
Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary t…
Smiths Medical ASD Inc.
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
ICU Medical, Inc.
H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SN…
WELCH ALLYN, INC/MORTARA
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.