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 356 of 819
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Cordis Corporation
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Medtronic CoreValve LLC
Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B3602…
Medicrea International
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Medtronic CoreValve LLC
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
CareFusion 303, Inc.
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Normand-Info S.A.S.U.
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Cathet…
RESPIRATORY THERAPEUTICS GROUP LLC
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Ster…
Bard Peripheral Vascular Inc
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Invivo Corporation
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits…
Covidien Llc
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Beckman Coulter Inc
CareFusion Alaris PCA Module, Model 8120
CareFusion 303, Inc.
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Beckman Coulter Inc
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Deroyal Industries, Inc. Lafollette
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for t…
Siemens Healthcare Diagnostics, Inc.
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Baxter Healthcare Corporation
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE …
Advanced Bionics, LLC
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Roche Diagnostics Operations, Inc.
CareFusion Alaris Pump Module, Model 8100
CareFusion 303, Inc.
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated a…
Vyaire Medical
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
Seca
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Beckman Coulter Inc
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is…
Siemens Healthcare Diagnostics, Inc.
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion…
Organ Recovery Systems, Inc.
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Tosoh Bioscience Inc
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Biofire Defense
CareFusion Alaris Syringe Module, Model 8110
CareFusion 303, Inc.
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measur…
Polymer Technology Systems, Inc.
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Deroyal Industries, Inc. Lafollette
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnosti…
Beckman Coulter Inc
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Ind…
Medtronic, PLC
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Deroyal Industries, Inc. Lafollette
Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 076133…
Stryker Corporation
Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnos…
Beckman Coulter Inc
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, …
Bard Peripheral Vascular Inc
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Siemens Healthcare Diagnostics, Inc.
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001…
Covidien Llc
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Deroyal Industries, Inc. Lafollette
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Steril…
Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Ste…
Bard Peripheral Vascular Inc
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Deroyal Industries, Inc. Lafollette
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2H…
Microvention, Inc.
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Biomet 3i, LLC
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, …
Microvention, 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.