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 33 of 810

FDA Devices Critical Dec 3, 2025

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Glycar SA Pty., Ltd.

FDA Devices Moderate Dec 3, 2025

FlexLab (FLX); Version: FLX-217-40;

Inpeco S.A.

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

The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is…

Magellan Diagnostics, 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

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

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

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

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

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

IntelePACS - InteleConnect / TechPortal

INTELERAD MEDICAL SYSTEMS INCORPORATED

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

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

FDA Devices Moderate Dec 3, 2025

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model…

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Dec 3, 2025

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

BioFire Diagnostics, 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

ULTRASITE 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

CARESAFE 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

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

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

FlexLab (FLX); Version: FLX-217-10;

Inpeco S.A.

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

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Dec 3, 2025

Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

Pivotal Health Solutions, Inc.

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

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 Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

Stryker Corporation

FDA Devices Moderate Dec 3, 2025

B.BRAUN 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

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

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

Remel, 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

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 Drug Moderate Nov 26, 2025

McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgi…

DermaRite Industries, LLC

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic …

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Pr…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: Th…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The S…

ASP Global, LLC. dba Anatomy Supply Partners, 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.

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.