PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-01

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 698 of 822

FDA Devices Moderate Dec 3, 2014

The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic pr…

Summit Industries Inc.
FDA Devices Moderate Dec 3, 2014

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE…

Toshiba American Medical Systems Inc
FDA Devices Moderate Dec 3, 2014

Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid…

Remel Inc
FDA Devices Moderate Dec 3, 2014

Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control uni…

Market-Tiers Inc
FDA Devices Moderate Dec 3, 2014

Dharma Cavity Varnish with Fluoride

Dharma Research, Inc.
FDA Devices Moderate Dec 3, 2014

8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Moderate Dec 3, 2014

8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Moderate Dec 3, 2014

8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Moderate Dec 3, 2014

Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlle…

Respironics California Inc
FDA Devices Low Dec 3, 2014

LUNA Chest, Model No. LU4006

Novadaq Technologies, Inc.
FDA Devices Moderate Dec 3, 2014

IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model…

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Dec 3, 2014

8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Moderate Dec 3, 2014

8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Low Dec 3, 2014

Non-sterile drape

Novadaq Technologies, Inc.
FDA Devices Moderate Dec 3, 2014

8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Moderate Dec 3, 2014

7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of …

ZOLL Circulation, Inc.
FDA Devices Moderate Dec 3, 2014

8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Moderate Dec 3, 2014

Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial…

Zimmer, Inc.
FDA Devices Moderate Dec 3, 2014

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE T…

Toshiba American Medical Systems Inc
FDA Devices Moderate Dec 3, 2014

Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioni…

Materialise USA LLC
FDA Devices Moderate Dec 3, 2014

8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Intuitive Surgical, Inc.
FDA Devices Critical Dec 3, 2014

Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a…

Philips Medical Systems, Inc.
FDA Devices Moderate Dec 3, 2014

CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatm…

CooperSurgical, Inc.
FDA Devices Moderate Nov 26, 2014

UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

DRAPE 9732722 TUBE STERILE O-ARM 20PK

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

TUMOR RES. PACK 9733553 AxiEM S.M.

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports informati…

Elekta, Inc.
FDA Devices Low Nov 26, 2014

Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial su…

Biomerieux
FDA Devices Moderate Nov 26, 2014

CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment plan…

Accuray Incorporated
FDA Devices Moderate Nov 26, 2014

The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.

Medacta Usa
FDA Devices Moderate Nov 26, 2014

Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infir…

Silver Star Brands
FDA Devices Moderate Nov 26, 2014

KIT, 9731427, THORACIC TACTILE PROBES

Medtronic Navigation, Inc.
FDA Devices Low Nov 26, 2014

Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial sus…

Biomerieux
FDA Devices Moderate Nov 26, 2014

Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500…

Nidek Inc
FDA Devices Moderate Nov 26, 2014

ENT PRGM 9734636 ADD FUSION NAV AxiEM

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

MOUSE 9732721 STERILE O-ARM 10PK

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate Syste…

Monteris Medical Corp
FDA Devices Low Nov 26, 2014

Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial sus…

Biomerieux
FDA Devices Moderate Nov 26, 2014

SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System,…

Monteris Medical Corp
FDA Devices Moderate Nov 26, 2014

SPHERES 8801071 1/TRAY 12PK

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

TRAJ GUIDE KIT, 9733065, BIOPSY, EXT

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

BIT 9733516 2.9mm DRILL STERILE

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

SPHERES 8801075 5/TRAY 12PK

Medtronic Navigation, Inc.
FDA Devices Low Nov 26, 2014

Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial sus…

Biomerieux
FDA Devices Low Nov 26, 2014

ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog N…

Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Nov 26, 2014

TUMOR RESECTION KIT 9733607 NON-INVASIVE

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

SHUNT KIT 9733605 NON-INVASIVE

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

INSTRUMENT TRACKER 9733533XOM ENT 1PK

Medtronic Navigation, Inc.
FDA Devices Moderate Nov 26, 2014

10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal fem…

Synthes, Inc.
FDA Devices Moderate Nov 26, 2014

DISP 9730950 STRL SPHERE, 1 PK INSERT

Medtronic Navigation, 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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.