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 217 of 819

FDA Devices Moderate Dec 28, 2022

Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ…

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615

Corin Ltd
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1104CA-CLIN

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

HeartWare Model 1101

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

DeVilbiss Healthcare LLC
FDA Devices Moderate Dec 28, 2022

Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid…

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imagin…

GE Medical Systems, LLC
FDA Devices Low Dec 28, 2022

Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

Howmedica Osteonics Corp.
FDA Devices Moderate Dec 28, 2022

Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

Tomy International Inc.
FDA Devices Moderate Dec 28, 2022

Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215

Corin Ltd
FDA Devices Moderate Dec 28, 2022

2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 19071…

Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1103

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Abbott Molecular, Inc.
FDA Devices Moderate Dec 28, 2022

B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

B125M Patient Monitor, REF 6160000-004-XXXXXX

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1104

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.

Medical Action Industries, Inc. 306
FDA Devices Moderate Dec 28, 2022

Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit

Medical Action Industries, Inc. 306
FDA Devices Moderate Dec 28, 2022

Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid)…

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm ran…

PHONESOAP
FDA Devices Moderate Dec 28, 2022

Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Orga…

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

NuVasive Inc
FDA Devices Moderate Dec 28, 2022

B125P Patient Monitor (with E-module slot option), REF 6160000-002

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF MCS1705PU

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

B105M Patient Monitor, REF 6160000-003

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

Abbott Molecular, Inc.
FDA Devices Moderate Dec 28, 2022

Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation
FDA Devices Moderate Dec 28, 2022

HeartWare Model 1102

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYN…

Companion Medical, Inc.
FDA Devices Moderate Dec 28, 2022

Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ…

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1205

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1104JP

Heartware, Inc.
FDA Devices Moderate Dec 28, 2022

Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ …

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

B125M Patient Monitor, REF 6160000-005-XXXXXXX

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intr…

Natus Medical Incorporated
FDA Devices Moderate Dec 28, 2022

Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging source…

GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022

Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation
FDA Devices Moderate Dec 28, 2022

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation
FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,

Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022

DeRoyal MYELOGRAM PACK, REF 89-9304.05

DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022

DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11

DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,

Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022

DeRoyal VIT RD PACK 86ST, REF 89-7308.09

DeRoyal Industries Inc
FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump

ARROW INTERNATIONAL Inc.
FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump

ARROW INTERNATIONAL Inc.
FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump

ARROW INTERNATIONAL Inc.
FDA Devices Moderate Dec 21, 2022

DeRoyal FOOT PACK, REF 89-9252.08

DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022

DeRoyal PAIN TRAY, REF 89-10464.03

DeRoyal Industries 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

25,473 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.