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 · 2026-08-25

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 536 of 819

CPSC No agency class Jun 13, 2017

GTHI Recalls Climbing Belay Devices Due to Fall and Injury Hazards

Great Trango Holdings Inc. (GTHI), of Lafayette, Colo.
FDA Devices Moderate Jun 7, 2017

NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)

Philips Electronics North America Corporation
FDA Devices Moderate Jun 7, 2017

The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surg…

Acumed LLC
FDA Devices Moderate Jun 7, 2017

HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - …

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Cell Marque Corporation
FDA Devices Low Jun 7, 2017

Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, w…

Acumedia Manufacturers, Inc.
FDA Devices Low Jun 7, 2017

Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of c…

Randox Laboratories
FDA Devices Moderate Jun 7, 2017

Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endo…

Hans Pausch Rontgengeratebau Gmbh
FDA Devices Low Jun 7, 2017

Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with q…

Acumedia Manufacturers, Inc.
FDA Devices Moderate Jun 7, 2017

Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardi…

Vascular Solutions, Inc.
FDA Devices Moderate Jun 7, 2017

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

AbbVie Inc.
FDA Devices Moderate Jun 7, 2017

Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Cont…

Exact Sciences Corporation
FDA Devices Moderate Jun 7, 2017

AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

AbbVie Inc.
FDA Devices Low Jun 7, 2017

Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of g…

Acumedia Manufacturers, Inc.
FDA Devices Moderate Jun 7, 2017

Assist Bed Rail - 6632

Invacare Corporation
FDA Devices Moderate Jun 7, 2017

Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

Ethicon Endo-Surgery Inc
FDA Devices Low Jun 7, 2017

AIA-PACK TPOAb CONTROL SET

Tosoh Bioscience, Inc.
FDA Devices Moderate Jun 7, 2017

1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressur…

KCI USA, INC.
FDA Devices Moderate Jun 7, 2017

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

AbbVie Inc.
FDA Devices Moderate Jun 7, 2017

Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reag…

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnosti…

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

Toshiba American Medical Systems Inc
FDA Devices Moderate Jun 7, 2017

AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur in…

Zimmer Biomet, Inc.
FDA Devices Moderate Jun 7, 2017

Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

GE Healthcare, LLC
FDA Devices Moderate Jun 7, 2017

Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000

Cardinal Scale Mfg Co
FDA Devices Moderate Jun 7, 2017

Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with a…

Zimmer Biomet, Inc.
FDA Devices Low Jun 7, 2017

AIA-PACK TgAb CONTROL SET

Tosoh Bioscience, Inc.
FDA Devices Moderate Jun 7, 2017

Elecsys PreciControl Varia 3

Roche Diagnostics Corporation
FDA Devices Moderate Jun 7, 2017

Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagno…

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - A…

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.

Zimmer Biomet, Inc.
FDA Devices Moderate Jun 7, 2017

Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

Arrow International Inc
FDA Devices Moderate Jun 7, 2017

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lact…

Medtest Holdings, Inc.
FDA Devices Moderate Jun 7, 2017

SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SH…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical Jun 7, 2017

Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal dia…

Abbott Vascular
FDA Devices Moderate Jun 7, 2017

Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

Madison Polymeric Engineering
FDA Devices Moderate Jun 7, 2017

Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagno…

Cell Marque Corporation
FDA Devices Moderate Jun 7, 2017

Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Re…

Cell Marque Corporation
CPSC No agency class Jun 7, 2017

Nidec Motor Recalls Swimming Pool Motors Due to Electrical Shock Hazard

Nidec Motor Corp., of St. Louis, Mo.
FDA Devices Moderate May 31, 2017

Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single …

Cardinal Health 200, LLC
FDA Devices Moderate May 31, 2017

Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use d…

Cardinal Health 200, LLC
FDA Devices Moderate May 31, 2017

Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile singl…

Cardinal Health 200, LLC
FDA Devices Moderate May 31, 2017

Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devi…

Cardinal Health 200, LLC
FDA Devices Moderate May 31, 2017

Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devic…

Cardinal Health 200, LLC
FDA Devices Moderate May 31, 2017

Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan

Medtronic Inc., Cardiac Rhythm and Heart Failure
FDA Devices Moderate May 31, 2017

Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use device…

Cardinal Health 200, LLC

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.