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 246 of 819

FDA Devices Moderate Jun 8, 2022

MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jun 8, 2022

Sterile Epidural Tray Catalog Number: 6259R2

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Port Tray Catalog 7607

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

I.V. Start Kit Catalog 8172

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Nerve Block Tray Catalog Number: 9342

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Single Shot Epidural Tray Catalog Number: 6797R2

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Tornier, Inc

FDA Devices Critical Jun 8, 2022

In-Line ventilator adaptor

Baxter Healthcare Corporation

FDA Devices Moderate Jun 8, 2022

Universal Tray Catalog 1567

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

Intuitive Surgical, Inc.

FDA Devices Moderate Jun 8, 2022

NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

Medtronic Xomed, Inc.

FDA Devices Moderate Jun 8, 2022

Nerve Block Tray Catalog Number: 6796R3

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

XVIVO Organ Chamber REF 19020

XVIVO PERFUSION AB

FDA Devices Moderate Jun 8, 2022

SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

5 Prong Manifold Set (with Luer Connectors)

Baxter Healthcare Corporation

FDA Devices Moderate Jun 8, 2022

Cervical Tray Catalog 1089

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Stereo Breast Biopsy Tray Catalog Number: 2383R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jun 8, 2022

Pellet Insertion Tray Catalog Number: B1654

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

Bio-Rad Laboratories, Inc.

FDA Devices Moderate Jun 8, 2022

DYNEX Agility, Agility Analyzer, Model No. 67000

Dynex Technologies, Inc.

FDA Devices Moderate Jun 8, 2022

4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

3.2MM Pellet Insertion Tray Catalog Number: B1144

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to in…

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

FDA Devices Moderate Jun 8, 2022

Bone Marrow Biopsy Tray Catalog Number: 8917R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jun 8, 2022

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Effluent Sample Bag

Baxter Healthcare Corporation

FDA Devices Moderate Jun 8, 2022

Procedure Tray Catalog 1065

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Universal Nerve Block Tray Catalog Number: 9779

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Single Shot Epidural Tray Catalog 1292

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

SS 4.5MM Pellet Insertion Tray Catalog Number: B9807

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Single Shot Epidural Tray - 18G Catalog Number: 8139R2

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains …

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Jun 8, 2022

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

MicroPort Orthopedics Inc.

FDA Devices Moderate Jun 8, 2022

MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jun 8, 2022

Cervical Tray Catalog Number: 3765R2

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

Epidural Tray Catalog 1307

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

CVC Dressing Change Kit Catalog Number: 2491R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

3.2MM Pellet Insertion Tray Catalog Number: B7345R1

Busse Hospital Disposables, Inc.

FDA Devices Moderate Jun 8, 2022

I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822

Busse Hospital Disposables, 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 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.