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
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
40,910 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · NHTSA federal recall filings · 2026-08-31
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 663 of 819
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecologic…
CooperSurgical, Inc.
SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankl…
Stryker Endoscopy
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, espec…
Remel Inc
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to prov…
Merit Medical Systems, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro d…
Siemens Healthcare Diagnostics, Inc.
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Varian Medical Systems Inc
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic inst…
Stryker Sustainability Solutions
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure mo…
Teleflex Medical
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass proce…
Terumo Cardiovascular Systems Corp
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments…
Stryker Sustainability Solutions
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane dia…
Siemens Medical Solutions USA, Inc
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, espe…
Remel Inc
PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation o…
ArthroCare Medical Corporation
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology i…
Volcano Corporation
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous…
Unomedical As
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF …
DeRoyal Industries Inc
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling …
Orthofix, Inc
Otteroo Recalls Baby Floats Due to Drowning Risk from Deflations (Recall Alert)
Otteroo Corporation, of San Francisco, Calif.
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, a…
Synthes, Inc.
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
Hill-Rom, Inc.
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate …
Synthes, Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
Beaver-Visitec International Inc.
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
Vidacare Corporation
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The …
Stryker Instruments Div. of Stryker Corporation
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power…
CareFusion 303, Inc.
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, includi…
Intuitive Surgical, Inc.
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured d…
Smiths Medical ASD, Inc.
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiogra…
Mortara Instrument, Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-ca…
HeartWare Inc
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
Beaver-Visitec International Inc.
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD…
Becton Dickinson & Co.
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Fl…
MRP, LLC dba AMUSA
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Biomet, Inc.
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as…
Boston Scientific Corporation
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Beaver-Visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
Beaver-Visitec International Inc.
Neusoft NeuViz 64 Multi-slice CT Scanner System
Neusoft Medical System Co
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Amerx Health Care Corp.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
Beaver-Visitec International Inc.
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
CooperSurgical, Inc.
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the…
Medtronic Navigation, Inc.
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring…
Integra LifeSciences Corp.
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is applicatio…
Philips Ultrasound, Inc.
I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use…
Neuro Kinetics, Inc.
Bio Armor Carno Pump Plus Electrolytes 40 servings (Blue Raspberry), Distributed by Reaction Nutrition, Carnegie, PA
Reaction Nutrition LLC
Bio Armor Carno Pump Plus Electrolytes 40 servings (Cherry Lime), Distributed by Reaction Nutrition, Carnegie, PA
Reaction Nutrition LLC
Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Montana Compounding Pharmacy
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro …
Ortho-Clinical Diagnostics
MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Philips Medical Systems (Cleveland) Inc
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Fresenius Medical Care Holdings, 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.