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 231 of 819

FDA Devices Moderate Oct 19, 2022

Hobbs Posi-Stop Injection Needle Catalog Number: 4702

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6548

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 19, 2022

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6544

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Helical Retrieval Basket Catalog Number: 4824

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6568

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6582

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6567

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid mana…

Baxter Healthcare Corporation

FDA Devices Moderate Oct 19, 2022

Hobbs Helical Retrieval Basket Catalog Number: 4808

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6562

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement the…

Baxter Healthcare Corporation

FDA Devices Moderate Oct 19, 2022

Hobbs Helical Retrieval Basket Catalog Number: 4816

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Posi-Stop Injection Needle Catalog Number: 4704

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

Johnson & Johnson Surgical Vision, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Medical Grasping Forceps Catalog Number: 5008

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Positron Emission Tomography and Computed Tomography System, Model: uMI 550

Shanghai United Imaging Healthcare Co., Ltd.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6534

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Helical Retrieval Basket Catalog Number: 4830

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Retrieval Forceps Catalog Number: 5018

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.

Baxter Healthcare Corporation

FDA Devices Moderate Oct 19, 2022

Hobbs Medical Polypectomy Snare Catalog Number: 4564

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Catalog Number: 6535

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Scope Introducer Catalog Number: 4650

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Medical Polypectomy Snare Catalog Number: 7202

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replaceme…

Baxter Healthcare Corporation

FDA Devices Moderate Oct 19, 2022

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Helical Retrieval Basket Catalog Number: 4814

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

Steris Corporation

FDA Devices Moderate Oct 19, 2022

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Posi-Stop Injection Needle Catalog Number: 4720

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

COVID Test Kit Nonsterile

American Contract Systems, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Medical Polypectomy Snare Catalog Number: 4563

Hobbs Medical, Inc.

FDA Devices Moderate Oct 19, 2022

Hobbs Posi-Stop Injection Needle Catalog Number: 4712

Hobbs Medical, Inc.

FDA Devices Critical Oct 19, 2022

Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Jiangsu Well Biotech Co.,Ltd.

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.