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
Compiled from official public sources by the editorial process.
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 299 of 819

FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Low Mar 17, 2021

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

OraSure Technologies, Inc.
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of re…

Draeger Medical, Inc.
FDA Devices Moderate Mar 17, 2021

Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

Medical Components, Inc dba MedComp
FDA Devices Moderate Mar 17, 2021

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary enviro…

Physio-Control, Inc.
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyrogl…

Tosoh Bioscience Inc
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35

Medtronic Vascular
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respirat…

Draeger Medical, Inc.
FDA Devices Moderate Mar 17, 2021

SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moistu…

Sunstar Americas, Inc.
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation …

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Mar 17, 2021

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

Brainlab AG
FDA Devices Moderate Mar 17, 2021

System INFX-8000V

Canon Medical System, USA, INC.
FDA Devices Moderate Mar 17, 2021

Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.

Howmedica Osteonics Corp.
FDA Devices Moderate Mar 10, 2021

TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.

Johnson & Johnson Surgical Vision Inc
FDA Devices Moderate Mar 10, 2021

Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move…

G & H Wire Company
FDA Devices Moderate Mar 10, 2021

ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic…

Bovie Medical Corporation
FDA Devices Moderate Mar 10, 2021

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561…

Boston Scientific Corporation
FDA Devices Moderate Mar 10, 2021

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynami…

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 10, 2021

Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation…

ReNovo, Inc.
FDA Devices Moderate Mar 10, 2021

HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

Hamilton Co
FDA Devices Moderate Mar 10, 2021

Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscop…

Bovie Medical Corporation
FDA Devices Moderate Mar 10, 2021

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M0056…

Boston Scientific Corporation
FDA Devices Moderate Mar 10, 2021

Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: int…

BioFire Diagnostics, LLC
FDA Devices Moderate Mar 10, 2021

The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955…

Baxter Healthcare Corporation
FDA Devices Moderate Mar 10, 2021

BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.

BioFire Diagnostics, LLC
FDA Devices Moderate Mar 10, 2021

Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained…

Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Mar 10, 2021

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; …

Boston Scientific Corporation
FDA Devices Moderate Mar 10, 2021

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

Nihon Kohden America Inc
FDA Devices Moderate Mar 10, 2021

HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic su…

Bovie Medical Corporation
FDA Devices Moderate Mar 10, 2021

Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhor…

CooperSurgical, Inc.
FDA Devices Critical Mar 10, 2021

ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi…

Acist Medical Systems
FDA Devices Moderate Mar 10, 2021

Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

Barco N.V.
FDA Devices Moderate Mar 3, 2021

PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with var…

Respironics California, LLC
FDA Devices Moderate Mar 3, 2021

Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventric…

Natus Manufacturing Limited
FDA Devices Moderate Mar 3, 2021

Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the g…

Northgate Technologies, 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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

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.