PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-29

Do more recalls mean more Class I danger?

Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-29. 2×2 strategic matrix plotting 7 entities by Total recalls (count) (X) and Class I share of classified (%) (Y), with a crosshair dividing the plot into four quadrants. Large · Class I–heavySmaller · Class I–heavyLarge · fewer Class ISmaller · fewer Class I 010,00020,00030,00040,00050,000 0%20%40%60%80% Total recalls (count) Class I share of classified (%) Category volume vs Class I rate Signature insight Medical DevicesFoodDrugs & MedicationsChildren & Baby ProductsDietary SupplementsMeat & PoultryCosmetics & Personal Care
Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-29.
Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

CategoryRecallsVol %ileClassifiedClass IClass I %Rate %ile
Medical Devices41,07010040,7633,6539%14
Food25,5138625,22211,67646.3%86
Drugs & Medications14,4737114,4171,50810.5%29
Children & Baby Products4,017572,48335214.2%43
Dietary Supplements2,018431,99346623.4%71
Meat & Poultry1,672291,6721,14568.5%100
Cosmetics & Personal Care1,388141,28920315.7%57

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 180 of 822

FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

GS0008 2Y - Burn Pack - STL, Item Number 880082025

ROi CPS LLC
FDA Devices Moderate Oct 11, 2023

Incisive CT, software version 5.0

Philips Healthcare
FDA Devices Moderate Oct 11, 2023

Citrine Triple Quad Mass Spectrometer, Part Number 5063684

AB Sciex, LLC
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

4500MD Triple Quad Mass Spectrometer, Part Number 5032522

AB Sciex, LLC
FDA Devices Moderate Oct 11, 2023

Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint"

Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

Becton Dickinson Infusion Therapy Systems Inc.
FDA Devices Moderate Oct 11, 2023

Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-2400 SPiN Drive System SYS-2230 ig4 System V2, 230V, 50Hz SYS-2000 ig4 Image Guides System SYS-1500 SPiN View" System SYS-1000 ig4 Image Guides System SYS-0220 ig4 System, 220V, 50Hz SYS-

Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

Philips North America Llc
FDA Devices Moderate Oct 11, 2023

Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Oct 11, 2023

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Medtronic Neuromodulation
FDA Devices Moderate Oct 11, 2023

LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers

DKK Dai-Ichi Shomei Co., Ltd.
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

GE Medical Systems China Co., Ltd.
FDA Devices Moderate Oct 11, 2023

Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)

Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Blue Belt Technologies, Inc
FDA Devices Moderate Oct 11, 2023

IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

Icecure Medical Ltd
FDA Devices Moderate Oct 11, 2023

Puritan Bennett Cuff Pressure Manager, REF: 180-03

Covidien
FDA Devices Moderate Oct 11, 2023

therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

Qiagen GmbH
FDA Devices Moderate Oct 11, 2023

(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 11408424 & 11408425; MAGNETOM Free.Star 11408426 & 11408427; MAGNETOM Mica 11292557; MAGNETOM Sempra 10840815 & 10840816; MAGNETOM Spectra 10655588 & 10837643; (2) Over Ear Headphones SMN: 11060845 used with the

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 11, 2023

LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC

DKK Dai-Ichi Shomei Co., Ltd.
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Critical Oct 11, 2023

Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

ARROW INTERNATIONAL Inc.
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

Thoratec Corp.
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

API3200MD Mass Spectrometer, Part Number 4466230

AB Sciex, LLC
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx INS-5323 Sliding stopper INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx"

Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes INS-5700 SPiN EWC Biopsy Guide Kit

Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

Bard Peripheral Vascular Inc
FDA Devices Moderate Oct 11, 2023

EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359

Philips North America Llc
FDA Devices Critical Oct 11, 2023

Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter

ARROW INTERNATIONAL Inc.
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrat

Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Oct 11, 2023

Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010

Zimmer Surgical Inc
FDA Devices Moderate Oct 11, 2023

Citrine QTRAP Mass Spectrometer, Part Number 5063685

AB Sciex, LLC
FDA Devices Moderate Oct 11, 2023

Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023

Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

Getinge Usa Sales Inc
FDA Devices Critical Oct 11, 2023

Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days

ARROW INTERNATIONAL Inc.
FDA Devices Moderate Oct 4, 2023

3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles

3M Company - Health Care Business
FDA Devices Moderate Oct 4, 2023

BD Pyxis MedBank MedPass Software, REF: 139088-01

CareFusion 303, Inc.
FDA Devices Critical Oct 4, 2023

Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)

Philips Respironics, 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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.