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 · 2026-08-25
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 544 of 819
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neuro…
Zimmer Biomet, Inc.
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
2k Innovations Inc.
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
2k Innovations Inc.
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Roche Diagnostics Corporation
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
GE Healthcare, LLC
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220…
ConMed Corporation
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
2k Innovations Inc.
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Siemens Medical Solutions USA, Inc
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
2k Innovations Inc.
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-…
Nihon Kohden America Inc
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
GE Healthcare, LLC
Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Boston Scientific Corporation
Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street…
Welch Allyn Inc
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of rad…
RAYSEARCH LABORATORIES AB
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Micromedics, Inc.
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 …
ConMed Corporation
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radi…
Merit Medical Systems, Inc.
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
2k Innovations Inc.
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
2k Innovations Inc.
Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The device…
Draegar Medical Systems, Inc.
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 …
ConMed Corporation
Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and…
Ge Medical Systems Information T
Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devi…
Draegar Medical Systems, Inc.
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Roche Diagnostics Corporation
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Keystone Dental Inc
Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A …
Hill-Rom, Inc.
Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS…
Draegar Medical Systems, Inc.
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
2k Innovations Inc.
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: Th…
Volcano Corporation
Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
Windstone Medical Packaging, Inc.
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY…
Volcano Corporation
VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK Im…
BioMerieux SA
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, …
PerkinElmer Life and Analytical Sciences, Wallac, OY
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brai…
Medtronic Neurosurgery
Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
2k Innovations Inc.
ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stain…
Cardiovascular Systems 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.