PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-01

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 693 of 822

FDA Devices Moderate Dec 17, 2014

Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine i…

Instrumed International, Inc.

FDA Devices Moderate Dec 17, 2014

Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fract…

Instrumed International, Inc.

FDA Devices Moderate Dec 17, 2014

Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds…

Invacare Corporation

FDA Devices Moderate Dec 17, 2014

BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injurie…

Becton Dickinson & Company

FDA Devices Moderate Dec 17, 2014

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange…

Medtronic Perfusion Systems

FDA Devices Moderate Dec 17, 2014

Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical…

Instrumed International, Inc.

FDA Devices Moderate Dec 17, 2014

Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., …

Instrumed International, Inc.

FDA Devices Critical Dec 10, 2014

Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate w…

Customed, Inc

FDA Devices Critical Dec 10, 2014

ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

ConMed Corporation

FDA Devices Moderate Dec 10, 2014

Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carto…

Cure Medical LLC

FDA Devices Critical Dec 10, 2014

Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, …

Customed, Inc

FDA Devices Critical Dec 10, 2014

Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate …

Customed, Inc

FDA Devices Critical Dec 10, 2014

Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate …

Customed, Inc

FDA Devices Critical Dec 10, 2014

Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…

Customed, Inc

FDA Devices Critical Dec 10, 2014

OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed, Inc

FDA Devices Critical Dec 10, 2014

OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…

Customed, Inc

FDA Devices Critical Dec 10, 2014

O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wou…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, suture removals, …

Customed, Inc

FDA Devices Moderate Dec 10, 2014

Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intende…

Gambro Renal Products Inc

FDA Devices Critical Dec 10, 2014

Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Dec 10, 2014

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialize…

Siemens Medical Solutions USA, Inc

FDA Devices Critical Dec 10, 2014

Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate …

Customed, Inc

FDA Devices Critical Dec 10, 2014

Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, ir…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wo…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…

Customed, Inc

FDA Devices Moderate Dec 10, 2014

Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 4…

Teleflex Medical

FDA Devices Critical Dec 10, 2014

Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to perform patient care procedures such as wound healing, suture removals, …

Customed, Inc

FDA Devices Critical Dec 10, 2014

Angiography Pack, Catalog number 900-2038. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Dec 10, 2014

Amerigel Saturated Gauze Dressing Wound management

Amerx Health Care Corp.

FDA Devices Critical Dec 10, 2014

Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…

Customed, Inc

FDA Devices Critical Dec 10, 2014

ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed, Inc

FDA Devices Critical Dec 10, 2014

Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds,…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, …

Customed, Inc

FDA Devices Critical Dec 10, 2014

Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, sut…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr…

Customed, Inc

FDA Devices Critical Dec 10, 2014

MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNE…

ConMed Corporation

FDA Devices Critical Dec 10, 2014

Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, …

Customed, Inc

FDA Devices Critical Dec 10, 2014

CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -In…

ConMed Corporation

FDA Devices Critical Dec 10, 2014

Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures such as wound healing, suture r…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds,…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate w…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…

Customed, Inc

FDA Devices Critical Dec 10, 2014

Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care procedures such as wound healing, suture removals, i…

Customed, 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 Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.