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 412 of 819

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OU…

Abbott Gmbh & Co. KG
FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

McKesson Cardiology Hemo

Change Healthcare Israel Ltd.
FDA Devices Moderate Jun 5, 2019

Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat t…

PF Consumer Healthcare 1 LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324

Maquet Cardiovascular, LLC
FDA Devices Critical Jun 5, 2019

SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-192…

Terumo Medical Corporation
FDA Devices Moderate Jun 5, 2019

Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

Exactech, Inc.
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0

Teleflex Medical
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: …

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90

Exactech, 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.