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 53 of 810
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Le…
Thoratec LLC
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Beckman Coulter, Inc.
GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
3mensio Workstation (Vascular Fenestrated) software
PIE Medical Imaging B.V.
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Merit Medical Systems, Inc.
GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Empower Brands Recalls Remington Hair Dryers Due to Risk of Serious Injury or Death from Electrocution and Shock Hazards
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrig…
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refr…
AEQUITA PHARMACY
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigera…
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigera…
AEQUITA PHARMACY
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerat…
AEQUITA PHARMACY
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrig…
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Ref…
AEQUITA PHARMACY
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Ref…
AEQUITA PHARMACY
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refriger…
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refr…
AEQUITA PHARMACY
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refriger…
AEQUITA PHARMACY
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refriger…
AEQUITA PHARMACY
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter Inc.
GYN ROBOTIC PACK. Medical convenience kit.
AVID Medical, Inc.
LAP CHOLE PACK. Medical convenience kit.
AVID Medical, Inc.
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Beckman Coulter, Inc.
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Siemens Healthcare Diagnostics Inc
PACK GENERAL ROBOTIC. Medical convenience kit.
AVID Medical, Inc.
LAVH PACK. Medical convenience kit.
AVID Medical, Inc.
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Beckman Coulter, Inc.
LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
AVID Medical, Inc.
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
AVID Medical, Inc.
Plum Duo Infusion System, List Number: 400020401
ICU Medical, Inc.
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Becton, Dickinson and Company, BD Bio Sciences
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
AVID Medical, Inc.
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U…
Flexicare Medical (Dongguan) Ltd.
LAPAROSCOPIC GYN. Medical convenience kit.
AVID Medical, Inc.
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Flexicare Medical (Dongguan) Ltd.
LAPAROSCOPIC TRAY. Medical convenience kit.
AVID Medical, Inc.
ROBOTIC URO/GYN PACK. Medical convenience kit.
AVID Medical, Inc.
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Flexicare Medical (Dongguan) Ltd.
GYN LAPAROSCOPY PACK. Medical convenience kit.
AVID Medical, Inc.
ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.
AVID Medical, Inc.
BD Trucount Controls, 30 Test - REF: 340335
Becton, Dickinson and Company, BD Bio Sciences
GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
AVID Medical, Inc.
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
B BRAUN MEDICAL INC
GEN LAPAROSCOPY PACK. Medical convenience kit.
AVID Medical, Inc.
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Beckman Coulter, Inc.
LAPAROSCOPY PACK. Medical convenience kit.
AVID Medical, Inc.
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2…
CareFusion 303, Inc.
MAJOR THORACOSCOPY BASIN. Medical convenience kit.
AVID 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 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.