Product category · Updated Aug 19, 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 (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
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 705 of 822
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device …
Smith & Nephew, Inc.
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexe…
Nanosphere, Inc.
Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer …
Dako North America Inc.
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387,…
Spacelabs Healthcare Inc
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of th…
Philips Medical Systems (Cleveland) Inc
UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medic…
Argon Medical Devices, Inc
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administ…
ICU Medical, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add …
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flo…
Vapotherm, Inc.
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical venti…
Carefusion 2200 Inc
Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for u…
Vapotherm, Inc.
AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplan…
Siemens Medical Solutions USA, Inc
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemod…
Fresenius Medical Care Holdings, Inc.
ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are…
Horiba Instruments, Inc dba Horiba Medical
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed…
Nanosphere, Inc.
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, tra…
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separat…
Fresenius Medical Care Holdings, Inc.
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity be…
Data Innovations, LLC
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Amerx Health Care Corp.
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Motion Concepts
Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Li…
Advanced Photonic Systems, LLC
ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323…
Siemens Healthcare Diagnostics
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Amerx Health Care Corp.
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliq…
Genesis BPS, LLC.
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate,…
Fresenius Medical Care Holdings, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connectio…
Bio-Detek, Inc.
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, se…
Fresenius Medical Care Holdings, Inc.
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Des…
GF Health Products, Inc./d.b.a.Basic American Metal Products
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and prec…
Volcano Corporation
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer recons…
Philips Medical Systems (Cleveland) Inc
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD AD…
Siemens Healthcare Diagnostics
Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Sli…
Advanced Photonic Systems, LLC
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict…
Becton Dickinson & Co.
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23…
Varian Medical Systems, Inc.
Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Lig…
Advanced Photonic Systems, LLC
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultan…
Biofire Defense
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, t…
Fresenius Medical Care Holdings, Inc.
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Amerx Health Care Corp.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators f…
Bio-Detek, Inc.
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system…
Siemens Medical Solutions USA, Inc
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separat…
Fresenius Medical Care Holdings, Inc.
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. T…
Beckman Coulter Inc.
Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm…
Bard Peripheral Vascular Inc
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system d…
Siemens Healthcare Diagnostics, Inc.
Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare f…
ARJOHUNTLEIGH POLSKA SP. ZO.O.
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322…
Siemens Healthcare Diagnostics
B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutan…
B. Braun Medical, Inc.
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
JK Products & Services, Inc
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyze…
Diagnostica Stago, Inc.
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from…
Teleflex Medical
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 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.