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 · 2026-08-22
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 450 of 819
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Swissray Medical
Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications i…
Philips Electronics North America Corporation
AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including dia…
Philips Electronics North America Corporation
Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for…
Zimmer Biomet, Inc.
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vi…
Bausch & Lomb Inc
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Medtronic Navigation, Inc.
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compr…
Biomet UK Ltd.
Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary …
Zimmer Biomet, Inc.
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit…
Bausch & Lomb Inc
INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
Philips Electronics North America Corporation
INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…
Philips Electronics North America Corporation
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Terumo Cardiovascular Systems Corporation
AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagno…
Philips Electronics North America Corporation
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and …
Boston Scientific Corporation
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Boston Scientific Corporation
Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…
Philips Electronics North America Corporation
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic pol…
Reckitt Benckiser LLC
Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diag…
Philips Electronics North America Corporation
The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral va…
Shockwave Medical, Inc.
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine…
Medtronic Neurosurgery
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone F…
Degania Silicone, Ltd.
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals under…
Exactech, Inc.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-way si…
Degania Silicone, Ltd.
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems Inc
Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
Degania Silicone, Ltd.
Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag)…
ShinChang Medical Co., Ltd.
Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter wit…
Degania Silicone, Ltd.
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 42191…
bioMerieux, Inc.
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter wi…
Degania Silicone, Ltd.
Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
Zimmer Biomet, Inc.
4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
Arrow International Inc
Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter wi…
Degania Silicone, Ltd.
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems Inc
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems Inc
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, P…
Biocare Medical, LLC
Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way silicone Fo…
Degania Silicone, Ltd.
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose …
Medtronic Inc.
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems Inc
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Accuray Incorporated
Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
Degania Silicone, Ltd.
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 41857…
bioMerieux, Inc.
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems Inc
IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all…
Stryker Medical Division of Stryker Corporation
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic…
Ortho-Clinical Diagnostics
AIRO Mobile CT System Model # MobiCT-32
Mobius Imaging, LLC
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way si…
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
Degania Silicone, Ltd.
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
Ventana Medical Systems Inc
Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter wit…
Degania Silicone, Ltd.
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Siemens Medical Solutions USA, 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.