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 413 of 819

FDA Devices Moderate Jun 5, 2019

Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

King LTS-D Kit Size 1, Model Number KLTSD431

King Systems Corp. dba Ambu, Inc.
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 15705 Material: 701051122

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

Abbott Laboratories Inc. (St Jude Medical)
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiogra…

NeuroLogica Corporation
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0

Teleflex Medical
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45

Exactech, Inc.
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Horizon Cardiology Hemo

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

Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

Abbott Vascular
FDA Devices Critical Jun 5, 2019

Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

Terumo Medical Corporation
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372

Maquet Cardiovascular, LLC
FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01

Maquet Cardiovascular, LLC

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.