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 publisher.
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

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

40,910 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · NHTSA federal recall filings · 2026-08-26

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 550 of 819

FDA Devices Moderate Mar 29, 2017

Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconst…

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Mar 29, 2017

Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging…

Devicor Medical Products Inc
FDA Devices Moderate Mar 29, 2017

ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicr…

BioMerieux SA
FDA Devices Moderate Mar 29, 2017

AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
FDA Devices Moderate Mar 29, 2017

Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Compon…

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Mar 29, 2017

IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on…

Ohmeda Medical
FDA Devices Moderate Mar 29, 2017

Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

CareFusion 303, Inc.
FDA Devices Moderate Mar 29, 2017

Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). I…

Ohmeda Medical
FDA Devices Moderate Mar 29, 2017

Mevatron M2/Primus Mid-Energy PRIMUS HI

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 29, 2017

Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient …

Teleflex Medical
FDA Devices Moderate Mar 29, 2017

ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determ…

BioMerieux SA
FDA Devices Moderate Mar 29, 2017

Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recons…

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Mar 29, 2017

Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient l…

Ohmeda Medical
FDA Devices Moderate Mar 29, 2017

Raindrop Near Vision Inlay, Model# RD1-1

Revision Optics Inc
FDA Devices Moderate Mar 29, 2017

ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antim…

BioMerieux SA
FDA Devices Moderate Mar 29, 2017

ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antim…

BioMerieux SA
FDA Devices Moderate Mar 29, 2017

Hitachi Echelon Oval MRI System

Hitachi Medical Systems America Inc
FDA Devices Moderate Mar 29, 2017

Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Compon…

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Mar 29, 2017

ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial su…

BioMerieux SA
FDA Devices Moderate Mar 29, 2017

ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial…

BioMerieux SA
FDA Devices Moderate Mar 29, 2017

ARTISTE" MV System

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 29, 2017

Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly C…

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Mar 29, 2017

Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use …

Nidek Inc
FDA Devices Moderate Mar 29, 2017

LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile

Tearscience, Inc
CPSC No agency class Mar 24, 2017

OPW Recalls Gas Station Hose Swivel Connectors Due to Fire, Explosion Hazards

OPW, of Hamilton, Ohio
FDA Drug Low Mar 22, 2017

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K24…

Pharmedium Services, LLC
FDA Devices Moderate Mar 22, 2017

Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration …

Inion Ltd.
FDA Devices Moderate Mar 22, 2017

882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform p…

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Mar 22, 2017

L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for int…

Kiscomedica S.A.
FDA Devices Moderate Mar 22, 2017

Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

CORENTEC CO., LTD
FDA Devices Moderate Mar 22, 2017

Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.

Smiths Medical ASD Inc.
FDA Devices Moderate Mar 22, 2017

ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry …

Radiometer America Inc
FDA Devices Moderate Mar 22, 2017

RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications

RTI Surgical, Inc.
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

Eclipse Hypodermic Needle

Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2017

VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with…

Maquet Cardiovascular, LLC
FDA Devices Moderate Mar 22, 2017

Toshiba Kalare DREX-KL80 X-ray generator

Toshiba American Medical Systems Inc
FDA Devices Moderate Mar 22, 2017

Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell…

Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Nu…

Ortho-Clinical Diagnostics
FDA Devices Moderate Mar 22, 2017

Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide …

Del Mar Reynolds Medical, Ltd.
FDA Devices Moderate Mar 22, 2017

Artis Q and Q.Zen fluoroscopic x-ray system

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is th…

C2 Therapeutics, Inc.
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50

LeMaitre Vascular, Inc.
FDA Devices Moderate Mar 22, 2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53

LeMaitre Vascular, 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.