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
Check a product → All categories

Medical Devices accounts for 40,910 recalls, about 39.3% of the federal recall archive, of which 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 104,020-record archive. 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
  • 39.3% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,910 recalls, about 39.3% of the 104,020-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.

40,910
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 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 185 of 819

FDA Devices Moderate Aug 9, 2023

Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical…

Olympus Corporation of the Americas

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYN…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems…

NeuMoDx Molecular Inc

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: D…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM

Covidien, LLC

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Mode…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number:…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Nu…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I;…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number:…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHE…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

Philips North America

FDA Devices Moderate Aug 9, 2023

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

Maquet Cardiovascular, LLC

FDA Devices Moderate Aug 9, 2023

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for car…

Maquet Cardiovascular, LLC

FDA Devices Moderate Aug 9, 2023

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

Maquet Cardiovascular, LLC

FDA Devices Moderate Aug 9, 2023

OEC Flexiview 8800 Systems with 9-inch Image Intensifier

GE OEC Medical Systems, Inc

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CD…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number:…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic r…

Wilson-Cook Medical Inc.

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, M…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A;…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE I…

GE OEC Medical Systems, Inc

FDA Devices Moderate Aug 9, 2023

Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and…

Olympus Corporation of the Americas

FDA Devices Moderate Aug 9, 2023

MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulat…

Megadyne Medical Products, Inc.

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Mode…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Allura Xper FD10 and FD20. X-ray Imaging System.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYN…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model N…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Nu…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

Johnson & Johnson Surgical Vision, Inc.

FDA Devices Moderate Aug 9, 2023

Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical…

Olympus Corporation of the Americas

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions an…

Olympus Corporation of the Americas

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Num…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

OEC 9900 Systems with 9-inch Image Intensifier

GE OEC Medical Systems, Inc

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, M…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model N…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 9, 2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Aug 9, 2023

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

Abiomed, 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.

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.