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 259 of 819
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
XTANT Medical
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareMana…
Philips North America Llc
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Baxter Healthcare Corporation
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Microbiologics Inc
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbe…
Covidien Llc
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
MEDLINE INDUSTRIES, LP - Northfield
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Siemens Medical Solutions USA, Inc.
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized…
CELLTRION USA INC
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Empowered Diagnostics LLC
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: …
Immuno-Mycologics, Inc
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accom…
Young Dental Mfg Co I LLC
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Luminex Corporation
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Smith & Nephew, Inc.
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Empowered Diagnostics LLC
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
Premier Rotaclone, Rx only
MEDLINE INDUSTRIES, LP - Northfield
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole M…
Abiomed, Inc.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Baxter Healthcare Corporation
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge …
Edge Pharma, LLC
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LL…
Edge Pharma, LLC
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr.…
Edge Pharma, LLC
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 0544…
Edge Pharma, LLC
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; indi…
Edge Pharma, LLC
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pres…
Philips Respironics, Inc.
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
GE Healthcare, LLC
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Siemens Medical Solutions USA, Inc
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
GE Healthcare, LLC
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Siemens Medical Solutions USA, Inc
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Console"
GE Healthcare, LLC
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Siemens Medical Solutions USA, Inc
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses minia…
Biomerieux Inc
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
NRT X-RAY A/S
8mm FlexDex Needle Driver, Product Code FD-335 ND
FlexDex Inc.
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
GE Healthcare, LLC
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent po…
Philips Respironics, Inc.
PIVO Blood Collection Device 20G, REF: 202-0005
Velano Vascular
MAGEC 1 System
NuVasive Specialized Orthopedics, Inc.
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Philips North America Llc
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) …
ev3 Inc.
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Covidien, LP
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 45…
Greiner Bio-One North America, Inc.
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.