Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
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 86 of 808
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the pat…
Spacelabs Healthcare, Ltd.
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use i…
Kirwan Surgical Products, LLC
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electri…
CooperSurgical, Inc.
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Augustine Temperature Management, LLC
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intend…
CooperSurgical, Inc.
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar…
Kirwan Surgical Products, LLC
Galaxy System (GAL-001)
Noah Medical
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging o…
GE OEC Medical Systems, Inc
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipo…
Kirwan Surgical Products, LLC
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anestheti…
Draeger Medical, Inc.
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Penc…
Kirwan Surgical Products, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refu…
Augustine Temperature Management, LLC
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-pow…
CooperSurgical, Inc.
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER …
Medtronic Neurosurgery
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered d…
CooperSurgical, Inc.
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551…
Spectranetics Corporation
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Micro-X Ltd.
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Nu…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Hologic, Inc
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Micro-X Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Micro-X Ltd.
BD Pyxis CII Safe ES, REF: 1116-00
CareFusion 303, Inc.
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, …
Cardinal Health 200, LLC
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
CareFusion 303, Inc.
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Cardinal Health 200, LLC
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Noah Medical
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolo…
ICU Medical, Inc.
BD Pyxis MedStation ES, REF: 323
CareFusion 303, Inc.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Diasorin Inc.
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Hermes Medical Solutions AB
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obtura…
Folsom Metal Products, Inc.
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Microline Surgical, Inc.
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid …
Beckman Coulter Inc.
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small …
Folsom Metal Products, Inc.
Non-ablative Fractional Laser Systems, Model: WFB-01
WINGDERM ELECTRO-OPTICS LTD.
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C…
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M…
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4)…
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780…
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
GE Healthcare (China) Co., Ltd.
Ziehm Solo. Digital Mobile C-arm
Orthoscan, Inc.
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Orthoscan, 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
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
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.