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 editorial process.
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

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 258 of 819

FDA Devices Low Feb 16, 2022

KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuc…

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imagi…

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical pr…

Smith & Nephew, Inc.
FDA Devices Moderate Feb 16, 2022

QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959…

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA …

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized micr…

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484

Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484

Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

R82 by ETAC Push Brace for High-Low

R82 A/S
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary suppor…

Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging sy…

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482

Baxter Healthcare Corporation
FDA Devices Low Feb 16, 2022

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism stra…

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ

Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022

LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial…

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganis…

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

CURAD REUSABLE GEL HOT/COLD PACK

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 16, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482

Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 1547060…

DePuy Orthopaedics, Inc.
FDA Devices Moderate Feb 16, 2022

KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pa…

Microbiologics Inc
FDA Devices Moderate Feb 16, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography…

GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022

BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

Becton Dickinson & Co.
FDA Devices Moderate Feb 16, 2022

GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3…

GE Healthcare, LLC
FDA Devices Moderate Feb 9, 2022

The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity…

FEMSelect Ltd
FDA Devices Moderate Feb 9, 2022

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a round…

DIXI MEDICAL USA
FDA Devices Moderate Feb 9, 2022

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a round…

DIXI MEDICAL USA
FDA Devices Low Feb 9, 2022

KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.

Microbiologics Inc
FDA Devices Moderate Feb 9, 2022

Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 30…

LivaNova USA, Inc.
FDA Devices Low Feb 9, 2022

KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(…

Microbiologics Inc
FDA Devices Moderate Feb 9, 2022

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflat…

Olympus Corporation of the Americas

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.