PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

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

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Compiled from official public sources by the editorial process.
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

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 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 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 163 of 808

FDA Devices Moderate Nov 1, 2023

Universal Viewer Workflow Manager, Image processing radiological system

GE Healthcare
FDA Devices Moderate Nov 1, 2023

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Nov 1, 2023

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. …

Maquet Cardiovascular, LLC
FDA Devices Moderate Nov 1, 2023

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Vasc. Open CVOR SJH, REF SJVO56B

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc
FDA Devices Critical Nov 1, 2023

Astral 100 and Astral 150 ventilators

ResMed Ltd.
FDA Devices Critical Nov 1, 2023

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

B. Braun Medical, Inc.
FDA Devices Moderate Nov 1, 2023

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Smiths Medical ASD Inc.
FDA Devices Moderate Nov 1, 2023

TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

Acclarent, Inc.
FDA Devices Moderate Nov 1, 2023

Lem Fertility hCG Pregnancy Urine Test REF 100-12

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

GE Healthcare
FDA Devices Moderate Nov 1, 2023

SOZO Bilateral Arm L-Dex Software

Impedimed Limited
FDA Devices Moderate Nov 1, 2023

OMTMO One Step Ovulation (LH) Test Strips REF 200-07

Universal Meditech Inc.
FDA Devices Critical Nov 1, 2023

Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC
FDA Devices Moderate Nov 1, 2023

One Step Pregnancy Test REF 100-01

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

CVS PCSU SJH, REF SJCV48J

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

Pediatric Heart SJH, REF SJPH34K

American Contract Systems, Inc.
FDA Devices Critical Nov 1, 2023

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC
FDA Devices Moderate Nov 1, 2023

OPMI LUMERA 300, REF 6137

Carl Zeiss Suzhou Co., Ltd.
FDA Devices Moderate Nov 1, 2023

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

Smith & Nephew, Inc.
FDA Devices Moderate Nov 1, 2023

Cath Cardiac Pack, REF IHCC03V

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Robotics Pack, REF SSRO22D

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS One Step LH Ovulation Test Strip REF 200-07

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

Omega Medical Imaging, Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27

Universal Meditech Inc.
FDA Devices Critical Nov 1, 2023

Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC
FDA Devices Moderate Nov 1, 2023

HealthyWiser UriTest" UTI Test Strips REF 900-UTI

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Sub Q Recorder Pack, REF BPRC87A

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

Smith & Nephew, Inc.
FDA Devices Moderate Nov 1, 2023

HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Nov 1, 2023

DiagnosUS Ovulation Predictor Midstream REF 200-17

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Breast Plastics Pack, REF BBPL20D

American Contract Systems, Inc.
FDA Devices Moderate Nov 1, 2023

Lem Fertility LH Ovulation Test (Strip) REF 200-07

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

One Step Ovulation Test REF 200-01

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods o…

EMPATICA SRL
FDA Devices Moderate Nov 1, 2023

Centricity Universal Viewer Workflow Manager, Image processing radiological system

GE Healthcare
FDA Devices Moderate Nov 1, 2023

HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips

Universal Meditech Inc.
FDA Devices Moderate Nov 1, 2023

Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Preat Corp
FDA Devices Critical Nov 1, 2023

Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC
FDA Devices Moderate Nov 1, 2023

Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

Preat Corp
FDA Devices Moderate Nov 1, 2023

To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10

Universal Meditech 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

25,184 recalls →

Drugs & Medications

14,290 recalls →

Vehicles

8,800 recalls →

Children & Baby Products

3,963 recalls →

Household Products

3,538 recalls →

Dietary Supplements

2,006 recalls →

Data sources

Category data as of Jul 2, 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 2, 2026.