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 386 of 819

FDA Devices Moderate Oct 16, 2019

iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

Conformis, Inc.
FDA Devices Moderate Oct 16, 2019

Achilles Insight Bone Sonometer

GE Healthcare, LLC
FDA Devices Moderate Oct 16, 2019

INVASIVE PROCEDURE TRAY MNS9510

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

Leica Biosystems Imaging, Inc.
FDA Devices Moderate Oct 16, 2019

CVC BUNDLE, 20CM, 3L, PI ECVC5120A

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

INFUSA PORT KIT DYNDC1840E

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Singl…

TriMed Inc.
FDA Devices Moderate Oct 16, 2019

CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

Becton Dickinson & Company
FDA Devices Moderate Oct 16, 2019

YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X …

K2M, Inc
FDA Devices Moderate Oct 16, 2019

IV SECUREMENT KIT IVS3405

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

CAP CHANGE KIT DYNDC1496B

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences
FDA Devices Moderate Oct 16, 2019

STERILE CAP CHANGE KIT DYNDC1946B

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type,…

Vital Scientific N.V.
FDA Devices Moderate Oct 16, 2019

TRIPLE LUMEN BUNDLE KIT ECVC1540

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

INFUSA PORT KIT DYNDC1840F

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Oct 16, 2019

Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant…

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

UVC TRAY UVT875

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

IV START KIT IV8440

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of …

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Oct 16, 2019

iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

Conformis, Inc.
FDA Devices Moderate Oct 16, 2019

VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Oct 16, 2019

PORT AND IO ACCESS DRESSING KIT DT15780A

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

Ethicon, Inc.
FDA Devices Moderate Oct 16, 2019

CENTRAL LINE BUNDLE ECVC6375

Centurion Medical Products Corporation
FDA Devices Low Oct 16, 2019

EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H938…

Baxter Healthcare Corporation
FDA Devices Moderate Oct 16, 2019

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771

Stryker Neurovascular
FDA Devices Moderate Oct 16, 2019

AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI sy…

GE Healthcare, LLC
FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences
FDA Devices Moderate Oct 16, 2019

BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

Becton Dickinson & Company
FDA Devices Moderate Oct 16, 2019

BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

Becton Dickinson & Company
FDA Devices Moderate Oct 16, 2019

IV KIT - SORBAVIEW IVS3475

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

CAP BUNDLE KIT DYNDC2137

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-ter…

Arrow International Inc
FDA Devices Moderate Oct 16, 2019

PEDIATRIC PICC INSERTION TRAY CVI4450

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974

Becton Dickinson & Company
FDA Devices Moderate Oct 16, 2019

CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840

Centurion Medical Products Corporation
FDA Devices Moderate Oct 16, 2019

CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter d…

Becton Dickinson & Company
FDA Devices Moderate Oct 16, 2019

Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944

Horiba Instruments Incorporated
FDA Devices Moderate Oct 16, 2019

cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences
CPSC No agency class Oct 10, 2019

Carrier Recalls Carrier- and Bryant-Branded Heat Pumps Due to Fire Hazard
FDA Drug Moderate Oct 9, 2019

GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL …

KRS Global Biotechnology, Inc
FDA Drug Moderate Oct 9, 2019

NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce …

KRS Global Biotechnology, Inc
FDA Drug Moderate Oct 9, 2019

NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Rato…

KRS Global Biotechnology, Inc
FDA Drug Moderate Oct 9, 2019

Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce …

KRS Global Biotechnology, 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.