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
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 263 of 819
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Cardinal Health
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Covidien Llc
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Philips North America Llc
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progre…
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Covidien Llc
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Philips North America Llc
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologie…
Northgate Technologies, Inc.
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Philips North America Llc
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for…
Orchestrate Orthodontic Technologies, Inc.
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
Covidien Llc
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Pow…
Osteomed, LLC
Puritan Bennett 980 Series Ventilator,980X1ENAIQC
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
Covidien Llc
SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM;…
Argon Medical Devices, Inc
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
Covidien Llc
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Boston Scientific Corporation
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring …
Siemens Healthcare Diagnostics, Inc.
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 n…
MAX LUX CORP
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Wright Medical Technology Inc
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Boston Scientific Corporation
Total Thyroxine (T4) ELISA; REF EIA-1781
DRG International, Inc.
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Boston Scientific Corporation
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Howmedica Osteonics Corp.
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Beeken Biomedical, LLC
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring …
Siemens Healthcare Diagnostics, Inc.
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Randox Laboratories Ltd.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Howmedica Osteonics Corp.
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BAC…
BioFire Diagnostics, LLC
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
O&M HALYARD INC
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Boston Scientific Corporation
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23…
Magnolia Medical Technologies, Inc.
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Boston Scientific Corporation
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Thoratec Corp.
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End C…
NuVasive Specialized Orthopedics, Inc.
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Boston Scientific Corporation
GE Centricity Universal Viewer Zero Footprint Client
GE Healthcare, LLC
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous…
Cardiac Assist, 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.