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 368 of 819

FDA Devices Moderate Feb 5, 2020

(1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

Vitreq Bv
FDA Devices Moderate Feb 5, 2020

Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Feb 5, 2020

The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Pati…

Intuitive Surgical, Inc.
FDA Devices Moderate Feb 5, 2020

JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blo…

Haemonetics Corporation
FDA Devices Moderate Feb 5, 2020

JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blo…

Haemonetics Corporation
FDA Devices Moderate Feb 5, 2020

VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669

Vitreq Bv
FDA Devices Moderate Jan 29, 2020

Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

Koios Medical, Inc.
FDA Devices Moderate Jan 29, 2020

PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700

Polymer Technology Systems, Inc.
FDA Devices Moderate Jan 29, 2020

Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308

Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Jan 29, 2020

Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information s…

GE Healthcare, LLC
FDA Devices Moderate Jan 29, 2020

Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Palodex Group Oy
FDA Devices Moderate Jan 29, 2020

Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Palodex Group Oy
FDA Devices Moderate Jan 29, 2020

Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366

Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Jan 29, 2020

Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3

Isopure Corp
FDA Devices Moderate Jan 29, 2020

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

Isopure Corp
FDA Devices Moderate Jan 29, 2020

VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for…

Greiner Bio-One North America, Inc.
FDA Devices Moderate Jan 29, 2020

Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)

Isopure Corp
FDA Devices Moderate Jan 29, 2020

TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884

Acclarent, Inc.
FDA Devices Critical Jan 29, 2020

Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a w…

GE Healthcare, LLC
FDA Devices Moderate Jan 29, 2020

TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891

Acclarent, Inc.
FDA Devices Moderate Jan 29, 2020

Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Palodex Group Oy
FDA Devices Moderate Jan 29, 2020

Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Jan 29, 2020

Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

Polymer Technology Systems, Inc.
FDA Devices Moderate Jan 29, 2020

PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702

Polymer Technology Systems, Inc.
FDA Devices Moderate Jan 29, 2020

Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE…

Imactis
FDA Devices Moderate Jan 29, 2020

KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Palodex Group Oy
FDA Devices Moderate Jan 29, 2020

iChem VELOCITY Urine Chemistry Analyzer

Beckman Coulter Inc.
FDA Devices Moderate Jan 29, 2020

Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-…

Arrow International Inc
FDA Devices Moderate Jan 29, 2020

TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877

Acclarent, Inc.
FDA Devices Moderate Jan 29, 2020

Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

Medicrea International
FDA Devices Moderate Jan 29, 2020

Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

Polymer Technology Systems, Inc.
FDA Devices Moderate Jan 29, 2020

Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

Paltop Advanced Dental Solutions Ltd
FDA Devices Moderate Jan 29, 2020

Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

Medicrea International
FDA Devices Moderate Jan 29, 2020

Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH

Arrow International Inc
FDA Devices Critical Jan 29, 2020

Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a w…

GE Healthcare, LLC
FDA Drug Moderate Jan 22, 2020

LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion
FDA Drug Moderate Jan 22, 2020

TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800

Assurance Infusion

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.