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 · 2026-08-30

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 649 of 819

FDA Devices Moderate Sep 9, 2015

TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage:…

Covidien LLC

FDA Devices Moderate Sep 9, 2015

ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irr…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

HIP AND KNEE REPLACEMENT 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

GOWN POLYREINF XLGE TOWEL/W 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, su…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrol…

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Sep 9, 2015

CYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture …

Customed, Inc

FDA Devices Moderate Sep 9, 2015

FACE LIFT 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

EENT PACK I (1) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) A tracheobronchial suction catheter is a devic…

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

MAJOR LAP PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A tracheobronchial suction catheter is a…

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabi…

Synthes (USA) Products LLC

FDA Devices Moderate Sep 9, 2015

CESAREAN PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrig…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Produ…

Covidien LLC

FDA Devices Moderate Sep 9, 2015

LAPAROTOMY SURGICAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

RETINA PACK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

NEURO PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irri…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

FEMORAL ANGIOGRAPHY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, ir…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrig…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 …

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

ANGIOGRAPHY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irri…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device that is att…

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, i…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SM…

Limacorporate S.p.A

FDA Devices Moderate Sep 9, 2015

LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture …

Customed, Inc

FDA Devices Moderate Sep 9, 2015

MINOR PROCEDURE PACK 40/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

ANGIOGRAPHY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irr…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROSCOPY OB 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrig…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.

Transonic Systems Inc

FDA Devices Moderate Sep 9, 2015

BASIC PACK 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irriga…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROSCOPY GYN PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, i…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction catheter is a device that is attached t…

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

UROLOGY CUSTOMED PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigat…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is …

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

O.R. TOWELS 25/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, ir…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted bloo…

Beckman Coulter Inc.

FDA Devices Moderate Sep 9, 2015

UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigat…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

ANGIOGRAPHY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrig…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

SKIN STAPLE REMOVER KIT 80/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

SHOULDER PACK CUSTOMED 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem…

Customed, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROSC CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, ir…

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 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.