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
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 254 of 819

FDA Devices Moderate Mar 23, 2022

DREAMTOME 44-30MM/260CM Material Number: M00584050

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Microbiologics Inc

FDA Devices Low Mar 23, 2022

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

CellEra LLC

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-30-260-025 Material Number: M00573100

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-20-450-025 Material Number: M00573090

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

SAFE-T PLUS ATRAUMATIC ADULT LP TRAY

Bard Peripheral Vascular Inc

FDA Devices Low Mar 23, 2022

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopul…

LivaNova Deutschland GmbH

FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-20MM/260CM Material Number: M00584000

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the follow…

Siemens Medical Solutions USA, Inc.

FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-30MM/450CM Material Number: M00584030

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 49-20-260-035 Material Number: M00573000

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

DREAMTOME 44-30MM/450CM Material Number: M00584070

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use…

Abbott Laboratories, Inc

FDA Devices Moderate Mar 23, 2022

JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

LUMBAR PUNCTURE DRUG FREE TRAY 22G

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

LUMBAR PUNCTURE TRAY ADULT 18G X 3.5

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 44-20MM/260CM Material Number: M00583040

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G

Bard Peripheral Vascular Inc

FDA Devices Low Mar 23, 2022

20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box

CellEra LLC

FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-30MM/260CM Material Number: M00584010

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift…

Hill-Rom, Inc.

FDA Devices Moderate Mar 23, 2022

Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060

Boston Scientific Corporation

FDA Devices Low Mar 23, 2022

20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

CellEra LLC

FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 49-30MM/260CM Material Number: M00583010

Boston Scientific Corporation

FDA Devices Low Mar 23, 2022

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

CellEra LLC

FDA Devices Moderate Mar 23, 2022

RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-30-260-035 Material Number: M00573060

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-30-450-025 Material Number: M00573110

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-30-450-035 Material Number: M00573070

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-20-450-035 Material Number: M00573050

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, …

Hologic, Inc

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-30-260-025 Material Number: M00573100

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

LINQ II Insertable Cardiac Monitor

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Mar 23, 2022

SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 44-30MM/450CM Material Number: M00583070

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Bio-Rad Laboratories, Inc.

FDA Devices Moderate Mar 23, 2022

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Bio-Rad Laboratories, Inc.

FDA Devices Moderate Mar 23, 2022

LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 23, 2022

Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer

Bard Peripheral Vascular Inc

FDA Devices Low Mar 23, 2022

20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

CellEra LLC

FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-20-260-025 Material Number: M00573080

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250

Boston Scientific Corporation

FDA Devices Moderate Mar 23, 2022

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

GE Healthcare, LLC

FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-20MM/450CM Material Number: M00584020

Boston Scientific Corporation

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.

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.