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

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

40,910 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · NHTSA federal recall filings · 2026-08-26

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 555 of 819

FDA Devices Moderate Mar 8, 2017

Lap Gallbladder Pack, part number AMS3707

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Lower Extremity Pack, part number AMS4669

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Bayview Abdominoplasty Pack, part number 009079-1

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Hernia Pack, part number AMS3859

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Stem Pack, part number AMS5166

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Br…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 1, 2017

CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

Custom Medical Specialties, Inc.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701

Smith & Nephew, Inc.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

Smith & Nephew, Inc.

FDA Devices Moderate Mar 1, 2017

Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professional…

Philips Electronics North America Corporation

FDA Devices Moderate Mar 1, 2017

Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704

Smith & Nephew, Inc.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibili…

BioMerieux SA

FDA Devices Moderate Mar 1, 2017

Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tos…

Tosoh Smd Inc

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based O…

Cardiovascular Systems Inc

FDA Devices Moderate Mar 1, 2017

GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilit…

Vascular Solutions, Inc.

FDA Devices Low Mar 1, 2017

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

DeRoyal Industries Inc

FDA Devices Moderate Mar 1, 2017

Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703

Smith & Nephew, Inc.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Low Mar 1, 2017

AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

Applied Medical Technology Inc

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare,…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 1, 2017

Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706

Smith & Nephew, Inc.

FDA Devices Moderate Mar 1, 2017

Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 …

Reckitt Benckiser LLC

FDA Devices Moderate Mar 1, 2017

Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702

Smith & Nephew, Inc.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Moderate Mar 1, 2017

Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187…

Degania Silicone, Ltd.

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Low Mar 1, 2017

Daavlin Aquex (DAAV1000)

Hidrex GmbH

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., Ltd.

FDA Devices Low Mar 1, 2017

SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

DeRoyal Industries Inc

FDA Devices Moderate Mar 1, 2017

Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

Tosoh Bioscience, Inc.

FDA Devices Moderate Mar 1, 2017

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Mar 1, 2017

Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Biomet U.K., 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.