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 · 2026-08-28

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 608 of 819

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Ca…

Biomerieux Inc
FDA Devices Moderate May 18, 2016

Dimension Assays: Direct HDL Cholesterol (AHDL)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot Cinc…

Stryker Corporation
FDA Devices Moderate May 18, 2016

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Atlas Spine, Inc.
FDA Devices Moderate May 18, 2016

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distrib…

Applied Medical Resources Corp
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Triglycerides (TRIG)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

Ascom US, INC.
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bra…

Covidien LLC
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Uric Acid (URCA)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Novarad Corporation
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implanta…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

Neusoft Medical Systems Co., Ltd.
FDA Devices Moderate May 18, 2016

Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or pla…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and contro…

C.R. Bard, Inc.
FDA Devices Moderate May 18, 2016

Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175

Stryker Sustainability Solutions
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Enzymatic Creatine (ECRE)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot Cin…

Stryker Corporation
FDA Devices Moderate May 18, 2016

Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument …

Bradshaw Medical Inc.
FDA Devices Moderate May 18, 2016

Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is de…

Hamilton Medical, Inc.
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Lactate

Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Low May 18, 2016

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is …

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Dimension Assays: Uric Acid (URCA)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acut…

Medtronic
FDA Devices Moderate May 18, 2016

Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..

Stryker Sustainability Solutions
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: LDL Cholesterol, Direct

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY ENZYMATIC CREATININE_2

Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute…

Medtronic
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for impleme…

B Braun Medical Inc
FDA Devices Moderate May 11, 2016

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical syste…

Alcon Research, Ltd.
FDA Devices Moderate May 11, 2016

HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The …

Philips Electronics North America Corporation
FDA Devices Moderate May 11, 2016

TCM CombiM Modules 903-111

Radiometer America Inc
FDA Devices Moderate May 11, 2016

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
FDA Devices Moderate May 11, 2016

Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV Hig…

Biosense Webster, Inc.
FDA Devices Moderate May 11, 2016

MAKOplasty Hip Array Kit Laminate 150230

Mako Surgical Corporation
FDA Devices Moderate May 11, 2016

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Fujifilm Medical Systems U.S.A., 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.