Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 recalls
- FDA Food 35
FDA Food
35 recalls
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 660 of 819
Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 152…
Lincare, Inc.
VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd…
Lincare, Inc.
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiogra…
GE Healthcare
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesi…
Viewray Incorporated
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Biomet, Inc.
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
Covidien LLC
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Roche Diagnostics Operations, Inc.
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
Covidien LLC
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet p…
US Endoscopy Group Inc
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
Covidien LLC
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
Covidien LLC
GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…
GE Healthcare
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ult…
Siemens Medical Solutions USA, Inc.
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Biomet, Inc.
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
Covidien LLC
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the crea…
Roche Diagnostics Operations, Inc.
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
Covidien LLC
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic f…
Siemens Healthcare Diagnostics, Inc.
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Atrium Medical Corporation
Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Inf…
Tecan US, Inc.
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
Covidien LLC
JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRigh…
Justright Surgical, LLC
Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single …
Milestone Scientific, Inc.
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for …
Roche Diagnostics Operations, Inc.
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
Covidien LLC
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR syste…
Roche Diagnostics Operations, Inc.
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODUL…
Roche Diagnostics Operations, Inc.
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, …
Roche Diagnostics Operations, Inc.
GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic,…
GE Healthcare
GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…
GE Healthcare
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Atrium Medical Corporation
Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemod…
Covidien LLC
GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, int…
GE Healthcare
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
Covidien LLC
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P
Covidien LLC
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
Covidien LLC
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation syst…
Siemens Healthcare Diagnostics, Inc.
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
Covidien LLC
GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…
GE Healthcare
Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, 21762-1…
Sechrist Industries Inc
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets con…
Medtronic Navigation, Inc.
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…
Siemens Medical Solutions USA, Inc
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, v…
Siemens Healthcare Diagnostics, Inc
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
Covidien LLC
GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, int…
GE Healthcare
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventila…
Hamilton Medical, Inc.
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
Covidien LLC
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report,…
Siemens Medical Solutions USA, 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
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
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.