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 242 of 819
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Aesculap Implant Systems LLC
Aqualung Recalls i330R SCUBA Diving Computers Due to Injury and Drowning Hazards
Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding
TMC Acquisition LLC dba Tailor Made Compounding
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large,…
Waldemar Link GmbH & Co. KG (Mfg Site)
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Ventana Medical Systems Inc
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Wright Medical Technology, Inc.
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Isopure Corp
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
ProxiDiagnost N90. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
MiniMed 640G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
MiniMed 740G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic pros…
Waldemar Link GmbH & Co. KG (Mfg Site)
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Zeltiq Aesthetics, Inc
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Invacare Corporation
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Zeltiq Aesthetics, Inc
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Spectranetics Corporation
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arteri…
Siemens Healthcare Diagnostics Inc
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
Zeltiq Aesthetics, Inc
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Zeltiq Aesthetics, Inc
Ivenix Infusion System (IIS)
Ivenix, Inc.
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Cook Incorporated
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…
Fresenius Medical Care Holdings, Inc.
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
Medtronic MiniMed
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
SCIENCE & BIO MATERIALS
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE …
Alcon Research, LLC
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBpl…
Fresenius Medical Care Holdings, Inc.
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilati…
Breas Medical, Inc.
MiniMed 720G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Zeltiq Aesthetics, Inc
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Draeger Medical Systems, Inc.
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 …
Agilent Technologies, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…
Fresenius Medical Care Holdings, Inc.
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
MiniMed 780G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
Medtronic MiniMed
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, …
Waldemar Link GmbH & Co. KG (Mfg Site)
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000,…
DePuy Orthopaedics, Inc.
MiniMed 620G Insulin Pump (O.U.S. version)
Medtronic MiniMed
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
HAMILTON-H900 Humidifier, Models: 950001, 950004
Hamilton Medical AG
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrate…
Ortho-Clinical Diagnostics, Inc.
Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-28…
Waldemar Link GmbH & Co. KG (Mfg Site)
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Pea…
Ultradent Products, Inc.
MiniMed 630G Insulin Pump (U.S. and Canada Version)
Medtronic MiniMed
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Aesculap Implant Systems LLC
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Cordis US Corp
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a…
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.