PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

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

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 200 of 819

FDA Devices Critical May 24, 2023

VentStar Basic (P)250, MP00352

Draeger Medical, Inc.

FDA Devices Critical May 24, 2023

Anesthesia Circuit Kit Coax 3, MP02732

Draeger Medical, Inc.

FDA Devices Moderate May 24, 2023

CombiDiagnost R90 R1.1

Philips North America

FDA Devices Moderate May 24, 2023

Fisher Wallace Stimulator Models FW-100 and FW-200

Fisher Wallace Laboratories Inc.

FDA Devices Critical May 24, 2023

ASM Replacement Battery, Component Number SUB0000594

ICU Medical Inc

FDA Devices Moderate May 24, 2023

Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circui…

Dynasthetics LLC

FDA Devices Moderate May 24, 2023

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813

Philips North America

FDA Devices Moderate May 24, 2023

DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing cir…

Smiths Medical ASD Inc.

FDA Devices Critical May 24, 2023

Ventstar Coax 180, MP03374

Draeger Medical, Inc.

FDA Devices Critical May 24, 2023

Anesthesia Circuit Kit Coax 1, MP02730

Draeger Medical, Inc.

FDA Devices Critical May 24, 2023

VentStar Basic (N) 180, MP00353

Draeger Medical, Inc.

FDA Devices Moderate May 24, 2023

ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

Hiossen Inc.

FDA Devices Critical May 24, 2023

VentStar breathing bag Set (P) 110, MP00384

Draeger Medical, Inc.

FDA Devices Critical May 24, 2023

Anesthesia Circuit Kit Coax HEPA, MP17102

Draeger Medical, Inc.

FDA Devices Critical May 24, 2023

Ventstar Coax 230, MP03376

Draeger Medical, Inc.

FDA Devices Moderate May 24, 2023

Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

Steris Corporation

FDA Devices Moderate May 24, 2023

Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

Philips North America Llc

FDA Devices Critical May 24, 2023

VentStar Bag Set (N) 110, MP00383

Draeger Medical, Inc.

FDA Devices Moderate May 24, 2023

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814

Philips North America

FDA Devices Moderate May 24, 2023

DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

Beckman Coulter, Inc.

FDA Devices Moderate May 24, 2023

greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

Greiner Bio-One North America, Inc.

FDA Devices Critical May 24, 2023

VentStar Watertrap (P) 180 w/oLL, MP00362

Draeger Medical, Inc.

FDA Devices Critical May 24, 2023

Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 206…

ICU Medical Inc

FDA Devices Critical May 24, 2023

VentStar Coax (P) 150, MP00379

Draeger Medical, Inc.

FDA Devices Moderate May 24, 2023

3M Attest Steam Chemical Integrators, REF 1243A

3M Company - Health Care Business

FDA Devices Moderate May 24, 2023

DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing cir…

Smiths Medical ASD Inc.

FDA Devices Moderate May 24, 2023

Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL

Beckman Coulter Inc.

FDA Devices Critical May 24, 2023

ID Coax 180, MP03375

Draeger Medical, Inc.

FDA Devices Moderate May 24, 2023

YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR

Surgical Innovations Ltd

CPSC No agency class May 18, 2023

Polaris Recalls RZR Pro XP and Turbo R Recreational Off-Road Vehicles Due to Fire Hazard (Recall Alert)

FDA Drug Moderate May 17, 2023

Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only,…

Apotex Corp.

FDA Devices Critical May 17, 2023

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLE…

Cook Incorporated

FDA Devices Moderate May 17, 2023

Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM

Bard Peripheral Vascular Inc

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC

Cordis US Corp

FDA Devices Moderate May 17, 2023

PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approxim…

Ethicon, Inc.

FDA Devices Moderate May 17, 2023

M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall

New Wave Endo-Surgical, Corp.

FDA Devices Critical May 17, 2023

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 …

Cook Incorporated

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

Cordis US Corp

FDA Devices Moderate May 17, 2023

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Bio-Rad Laboratories, Inc.

FDA Devices Moderate May 17, 2023

Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate May 17, 2023

TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynec…

Technidata S.A.

FDA Devices Moderate May 17, 2023

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Merit Medical Systems, Inc.

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC

Cordis US Corp

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

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.