Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 57 of 810
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
STRATASYS LTD
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product C…
Baxter Healthcare Corporation
O-arm O2 Imaging System. Mobile X-Ray System.
Medtronic Navigation, Inc.-Boxborough
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
STRATASYS LTD
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004;…
Baxter Healthcare Corporation
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Preat Corp
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment …
Alcon Research LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edw…
Edwards Lifesciences, LLC
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edw…
Edwards Lifesciences, LLC
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Sti…
Neurovision Medical Products Inc
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Ver…
Alcon Research LLC
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
STRATASYS LTD
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
STRATASYS LTD
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Descript…
Edwards Lifesciences, LLC
SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihu…
Shenzhen Yihuachuang Technology, dba SPPTTY, of China
Philips eL18-4 EMT Transducer.
Philips Ultrasound, Inc
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
Philips C9-5EC Transducer.
Philips Ultrasound, Inc
Change Healthcare Cardiology Hemodynamics Software
CHANGE HEALTHCARE CANADA COMPANY
Servo-u Ventilator System. Model Number: 6688600.
Maquet Critical Care AB
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-501…
CORIN MEDICAL, LTD.
Philips eL18-4 Transducer.
Philips Ultrasound, Inc
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
C.R. Bard Inc
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sol…
Philips Respironics, Inc.
Philips C5-2 Transducer.
Philips Ultrasound, Inc
Philips L12-3 Transducer.
Philips Ultrasound, Inc
Philips X6-1 Transducer.
Philips Ultrasound, Inc
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the m…
HemoCue AB
Philips X8-2t Transducer.
Philips Ultrasound, Inc
Philips V6-2 Transducer.
Philips Ultrasound, Inc
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Siemens Healthcare Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid…
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 …
Ortho-Clinical Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Siemens Healthcare Diagnostics, Inc.
Philips S5-1 Transducer.
Philips Ultrasound, Inc
Philips S7-2 Transducer.
Philips Ultrasound, Inc
Philips 3D9-3v Transducer.
Philips Ultrasound, Inc
Philips X7-2t Transducer.
Philips Ultrasound, Inc
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based…
LUMITHERA INC
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC0…
MEDLINE INDUSTRIES, LP - Northfield
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Philips Respironics, Inc.
Philips X5-1 Transducer.
Philips Ultrasound, Inc
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
Philips S8-3t Transducer.
Philips Ultrasound, Inc
Philips XL14-3 Transducer.
Philips Ultrasound, Inc
Philips C5-1 Transducer.
Philips Ultrasound, Inc
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
C.R. Bard Inc
Philips L12-4 Transducer.
Philips Ultrasound, 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 Jun 3, 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 Jun 3, 2026.