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 615 of 819
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended t…
Philips Medical Systems, Inc.
The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray s…
Siemens Medical Solutions USA, Inc.
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceutica…
Siemens Medical Solutions USA, Inc.
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system.…
Implant Direct Sybron Manufacturing, LLC
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament inju…
Ossur H / F
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 …
Ossur H / F
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devi…
ICU Medical, Inc.
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Medtronic Neuromodulation
Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated micropartic…
Roche Diagnostics Operations, Inc.
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to liga…
Ossur H / F
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems develo…
Siemens Medical Solutions USA, Inc
30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile …
ICU Medical, Inc.
Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries …
Ossur H / F
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
Ossur H / F
Cios Alpha, mobile X-ray system
Siemens Medical Solutions USA, Inc
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile device…
ICU Medical, Inc.
Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
Ossur H / F
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and os…
Ossur H / F
Cardiosave Hybrid and rescue IABP
Maquet Datascope Corp - Cardiac Assist Division
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angio…
Siemens Medical Solutions USA, Inc
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 st…
Amd Ritmed
31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended f…
ICU Medical, Inc.
Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and oste…
Ossur H / F
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Ossur H / F
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Acce…
Wfr/aquaplast Corp
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Ossur H / F
AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiograp…
Siemens Medical Solutions USA, Inc
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging …
Siemens Medical Solutions USA, Inc
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Medtronic Inc.
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
PMBS, LLC
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile …
ICU Medical, Inc.
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuou…
Terumo Cardiovascular Systems Corporation
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is…
Biomet Spine, LLC
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereot…
Viewray Incorporated
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Synthes (USA) Products LLC
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography system…
Siemens Medical Solutions USA, Inc
MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, …
Beckman Coulter Inc.
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedu…
Siemens Medical Solutions USA, Inc
Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and os…
Ossur H / F
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Innovative Ophthalmic Products, Inc
Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
Ossur H / F
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer recon…
Siemens Medical Solutions USA, Inc
Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cav…
Pelton & Crane / Marus / DCI Equipment / KaVo
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.