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 · 2026-08-27
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 575 of 819
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, C…
ConMed Corporation
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis…
Zimmer Biomet, Inc.
25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Synergetics Inc
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Calix T PEEK Lumbar System, TLIF Trial
X Spine Systems Inc
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4…
Windstone Medical Packaging, Inc.
Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for gen…
Windstone Medical Packaging, Inc.
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual…
Vascular Solutions, Inc.
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen …
Teleflex Medical
Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has a…
ConMed Corporation
Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
SDMS (SenTec Digital Monitoring System)
SenTec AG
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for…
US Endoscopy Group Inc
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, an…
ConMed Corporation
Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lu…
Vascular Solutions, Inc.
Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, lap…
ConMed Corporation
Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating ro…
Windstone Medical Packaging, Inc.
Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience cus…
Windstone Medical Packaging, Inc.
Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of deat…
Heartware, Inc.
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Olympus Corporation of the Americas
Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixat…
Hand Biomechanics Lab Inc
Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access cathete…
Vascular Solutions, 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.