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 · 2026-08-24

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 505 of 819

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 …

Roche Diagnostics Corporation

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used…

Ormco/Sybronendo

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

Horiba Instruments, Inc dba Horiba Medical

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty bl…

Beaver-Visitec International Inc.

FDA Devices Moderate Feb 7, 2018

Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system…

Roche Diagnostics Corporation

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated…

C.R. Bard, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypas…

Maquet

FDA Devices Moderate Feb 7, 2018

Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

Baxter Healthcare Corporation

FDA Devices Moderate Feb 7, 2018

SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small…

MicroAire Surgical Instruments, LLC

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette…

Alere San Diego, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

Smiths Medical ASD Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM

Zimmer Biomet, 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.