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 · 2026-10-01

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 2026-10-01. 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 2026-10-01.
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 207 of 822

FDA Devices Moderate Apr 26, 2023

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 26, 2023

Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

NeuroLogica Corporation
FDA Devices Moderate Apr 26, 2023

INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Apr 19, 2023

Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)

Church & Dwight Inc
FDA Devices Moderate Apr 19, 2023

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

Howmedica Osteonics Corp.
FDA Devices Low Apr 19, 2023

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

AGILENT TECHNOLOGIES INC./US
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)

Edwards Lifesciences, LLC
FDA Devices Moderate Apr 19, 2023

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

Philips North America Llc
FDA Devices Moderate Apr 19, 2023

Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010

Covidien, LP
FDA Devices Moderate Apr 19, 2023

Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

Western/Scott Fetzer Company
FDA Devices Moderate Apr 19, 2023

Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

Philips North America Llc
FDA Devices Moderate Apr 19, 2023

Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

Philips North America Llc
FDA Devices Moderate Apr 19, 2023

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

Philips North America Llc
FDA Devices Moderate Apr 19, 2023

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Apr 19, 2023

Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Critical Apr 19, 2023

Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Fresenius Kabi USA, LLC
FDA Devices Moderate Apr 19, 2023

BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

Bio-Rad Laboratories, Inc.
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

Merit Medical Systems, Inc.
FDA Devices Moderate Apr 19, 2023

Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)

Covidien, LP
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)

Covidien, LP
FDA Devices Moderate Apr 19, 2023

Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.

Outset Medical, Inc.
FDA Devices Moderate Apr 19, 2023

Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)

Edwards Lifesciences, LLC
FDA Devices Moderate Apr 19, 2023

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

Bio-Rad Laboratories, Inc.
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

Howmedica Osteonics Corp.
FDA Devices Moderate Apr 19, 2023

Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)

Covidien, LP
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

Angiodynamics, Inc.
FDA Devices Moderate Apr 19, 2023

EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

Encore Medical, LP
FDA Devices Moderate Apr 19, 2023

Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
FDA Devices Moderate Apr 19, 2023

thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece wit

Solta Medical Inc
FDA Devices Moderate Apr 19, 2023

Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC
CPSC No agency class Apr 13, 2023

Moen Recalls Flo Battery Back-Ups for Flo Smart Water Monitors Due to Fire Hazard

Moen Incorporated, of North Olmsted, Ohio
FDA Devices Moderate Apr 12, 2023

CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Apr 12, 2023

Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 0

Remote Diagnostic Technologies Ltd.
FDA Devices Moderate Apr 12, 2023

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

Stryker Corporation
FDA Devices Moderate Apr 12, 2023

VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

Maquet Cardiovascular, LLC
FDA Devices Moderate Apr 12, 2023

Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

Medtronic Sofamor Danek USA 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.