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 · 2026-08-28
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 621 of 819
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean …
Volcano Corporation
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Philips Medical Systems (Cleveland) Inc
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Stryker Instruments Div. of Stryker Corporation
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Philips Medical Systems (Cleveland) Inc
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Zimmer Spine, Inc.
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction wit…
Mako Surgical Corporation
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usag…
Siemens Healthcare Diagnostics, Inc.
Karma Flexx Wheelchair Manual Wheelchair.
Karman Healthcare Inc
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Stryker Instruments Div. of Stryker Corporation
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Inte…
Covidien LLC
50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Stryker Instruments Div. of Stryker Corporation
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. I…
Argon Medical Devices, Inc
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN …
Ivoclar Vivadent, Inc.
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, dur…
Maquet Cardiovascular Us Sales, Llc
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis…
Zimmer Biomet, Inc.
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
Integrated Medical Systems Inc
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, st…
Siemens Medical Solutions USA, Inc
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile beari…
Zimmer Biomet, Inc.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Pe…
Sorin Group USA, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
Integrated Medical Systems Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Philips Electronics North America Corporation
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-t…
Cook Inc.
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, …
Zimmer Biomet, Inc.
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Philips Electronics North America Corporation
EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD P/N 70-0050-A22) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluorosc…
Regulatory Insight, Inc
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Draeger Medical, Inc.
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
Integrated Medical Systems Inc
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use…
Zimmer Biomet, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Philips Electronics North America Corporation
EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/pol…
Zimmer Biomet, Inc.
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer vari…
Zimmer Biomet, Inc.
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/…
Zimmer Biomet, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices 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.