PlainRecalls

Product category · Updated Jun 3, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,478
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.

  • 40,478 total recalls
  • 40.4% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.

40,478
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2567 3385 2655 3821 3004 3208 2360 2254 2607 3417 2992 1243

Source: FDA · CPSC · NHTSA As of Jun 3, 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 31 of 810

FDA Devices Moderate Dec 3, 2025

SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook P…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Out…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pum…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories a…

Noah Medical Corporation

FDA Devices Moderate Dec 3, 2025

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

FoundationOne CDx (F1CDx), RAL-0003 version 31.0

Foundation Medicine, Inc.

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

Cepheid

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook P…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pu…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pum…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-802…

Stryker Corporation

FDA Devices Moderate Dec 3, 2025

Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part …

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Dec 3, 2025

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP…

Stryker Corporation

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook P…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Out…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recur…

Argon Medical Devices, Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Straumann USA LLC

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump,…

B Braun Medical Inc

FDA Devices Moderate Dec 3, 2025

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump…

B Braun Medical 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.

Data sources

Category data as of Jun 3, 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 Jun 3, 2026.