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
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 375 of 819
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Viewray, Inc.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Encore Medical, Lp
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Cook Inc.
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
Cook Inc.
Monaco Radiation Treatment Planning System (RTP) System
Elekta Inc
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1)…
Volcano Corporation
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
Medtronic Navigation, Inc.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
Healix Knotless ADV BR 5.5 Suture Anchor
DePuy Mitek, Inc., a Johnson & Johnson Co.
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Medtronic Navigation, Inc.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of de…
Smiths Medical ASD Inc.
fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC …
QuVa Pharma, Inc.
fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar…
QuVa Pharma, Inc.
fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7747…
QuVa Pharma, Inc.
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70…
QuVa Pharma, Inc.
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7747…
QuVa Pharma, Inc.
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Medtronic Neuromodulation
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
CooperSurgical, Inc.
Quantam 2000 Electrosurgical Generator, Part number 909075.
CooperSurgical, Inc.
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Theralase Inc.
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 …
Stryker Instruments Div. of Stryker Corporation
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
GE Healthcare, LLC
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-13…
Stryker Instruments Div. of Stryker Corporation
Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Steris Corporation
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
NDDd Medical Technologies, Inc.
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking c…
Miami Device Solutions, LLC.
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Zimmer Biomet, Inc.
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
NDDd Medical Technologies, Inc.
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Theralase Inc.
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia mode…
Allergan PLC
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended us…
Brasseler USA I Lp
HeartStart XL+ Defibrillator/Monitor, Model 861290
Philips North America, LLC
Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used…
Steris Corporation
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is …
Lens.com
PANTERA Proximal Humerus Fracture Plate System
Toby Orthopaedics, Inc.
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
Zimmer Biomet, Inc.
Giraffe OmniBed infant warmer
GE Healthcare, LLC
Giraffe Incubator infant warmer
GE Healthcare, LLC
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warm…
GE Healthcare, LLC
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.