Product category · Updated Jul 29, 2026

Medical Devices recalls

Name: Medical Devices Recalls
Creator: PlainRecalls
License: https://creativecommons.org/publicdomain/zero/1.0/

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 publisher. · Updated August 2026

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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 · 2026-08-25

High severity

3,645
Moderate

36,211
Lower severity

1,054

FDA Devices

39,635
FDA Drug

934
CPSC

306
FDA Food

35

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 534 of 819

Where Medical Devices sits among all 12 categories

Recalls in Medical Devices

Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial …

Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions…

AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by w…

ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access a…

ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Devi…

Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS …

Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM

Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas …

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The Arrow(r) CVC is indicated to provide short-term…

Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial c…

Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,

KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.

Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features …

Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) op…

Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the…

LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic …

Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation…

Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is…

Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive ma…

Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigatio…

Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to t…

Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the…

Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial an…

Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the perip…

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Co…

Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that il…

Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Awa…

ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous …

Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tens…

Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated…

AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavia…

QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circ…

Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( …

Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the…

ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous…

ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid f…

Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions …

ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( …

Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. Th…

Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP…

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introd…

Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue Plus" an…

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid flu…

NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim…

MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barr…

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