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 675 of 819
RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302…
Siemens Healthcare Diagnostics Inc
Juno DFR X-ray system
Villa Radiology Systems LLC
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diab…
Medtronic MiniMed Inc.
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Halyard Health
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical Endo…
Intuitive Surgical, Inc.
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Siemens Healthcare Diagnostics, Inc
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary an…
Arjo Hospital Equipment AB
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Halyard Health
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures…
Zipline Medical
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Siemens Healthcare Diagnostics, Inc
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing …
DePuy Orthopaedics, Inc.
LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is i…
Biosense Webster, Inc.
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basings…
Remel Inc
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Siemens Healthcare Diagnostics, Inc
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
iCAD, Inc.
KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Halyard Health
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
INO Therapeutics (dba Ikaria)
Philips Medical System Allura Xper X-Ray Angiographic
Philips Medical Systems, Inc.
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon cou…
Arrow International Inc
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Richard Wolf Medical Instruments Corp.
Xoran MiniCAT X-ray imaging device
Xoran Technologies, LLC
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Maquet Cardiovascular Us Sales, Llc
Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, …
Baxter Corporation Englewood
Focal Sim radiation therapy treatment planning system
Elekta, Inc.
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
CooperSurgical, Inc.
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9…
Boston Scientific Corp
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during su…
Stryker Howmedica Osteonics Corp.
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or…
Zimmer, Inc.
Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin i…
Zipline Medical
Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures t…
Zipline Medical
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatmen…
Arjo Hospital Equipment AB
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complicati…
Arjo Hospital Equipment AB
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for exter…
Elekta, Inc.
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Baxter Healthcare Corp.
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbru…
Norwex Usa Inc
NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number…
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number…
Navilyst Medical, Inc
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip …
Zimmer Gmbh
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe…
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. N…
Navilyst Medical, Inc
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based m…
Hospira Inc.
Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
Zimmer Gmbh
NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. N…
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device Listing Num…
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number…
Navilyst Medical, Inc
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total h…
Zimmer Gmbh
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at r…
HeartWare Inc
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, …
Medtronic Neuromodulation
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device Listing Numbe…
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. N…
Navilyst Medical, 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.