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
Compiled from official public sources by the publisher.
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 · 2026-08-31

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 662 of 819

FDA Devices Moderate Jul 8, 2015

Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. …

Spine Wave, Inc.
FDA Devices Moderate Jul 8, 2015

Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409

Covidien LLC
FDA Devices Moderate Jul 8, 2015

LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprot…

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Jul 8, 2015

Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100

Atrium Medical Corporation
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C

Covidien LLC
FDA Devices Moderate Jul 8, 2015

StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablatio…

New Star Lasers, Inc.
FDA Devices Moderate Jul 8, 2015

Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total chole…

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Jul 8, 2015

JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight…

Justright Surgical, LLC
FDA Devices Moderate Jul 8, 2015

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

BioMerieux SA
FDA Devices Moderate Jul 8, 2015

Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 pl…

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Jul 8, 2015

Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applic…

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 8, 2015

Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infin…

Tecan US, Inc.
FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…

GE Healthcare
FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, int…

GE Healthcare
FDA Devices Moderate Jul 8, 2015

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreo…

Alcon Research, Ltd.
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of nat…

Vascutek, Ltd.
FDA Devices Moderate Jul 8, 2015

INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vin…

Intuitive Surgical, Inc.
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064

Covidien LLC
FDA Devices Moderate Jul 8, 2015

LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in…

LifeHealth, LLC
FDA Devices Moderate Jul 8, 2015

Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049

Covidien LLC
FDA Devices Moderate Jul 8, 2015

Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P

Covidien LLC
FDA Devices Moderate Jul 1, 2015

Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.

Hill-Rom, Inc.
FDA Devices Moderate Jul 1, 2015

NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concen…

Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jul 1, 2015

Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instrument…

Stryker Sustainability Solutions
FDA Devices Moderate Jul 1, 2015

Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-84…

X Spine Systems Inc
FDA Devices Moderate Jul 1, 2015

EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of s…

ArthroCare Medical Corporation
FDA Devices Moderate Jul 1, 2015

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

Smith & Nephew, Inc.
FDA Devices Moderate Jul 1, 2015

LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical…

Cook Inc.
FDA Devices Moderate Jul 1, 2015

Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #…

Ethicon, Inc.
FDA Devices Moderate Jul 1, 2015

Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels i…

Volcano Corporation
FDA Devices Moderate Jul 1, 2015

GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0…

GE Healthcare
FDA Devices Low Jul 1, 2015

The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs…

Bio-Rad Laboratories, 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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

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.