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 402 of 819
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Produc…
Bard Peripheral Vascular Inc
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
St Jude Medical Inc.
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; …
MED-EL Elektromedizinische Gereate, Gmbh
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmenta…
Geistlich Pharma North America, Inc.
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) -…
Bard Peripheral Vascular Inc
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
St Jude Medical Inc.
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone…
DRG Instruments GmbH
iCT SP Model # 728311, computed tomography x-ray system
Philips Medical Systems (Cleveland) Inc
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialys…
Medical Components, Inc dba MedComp
VITROS 4600 Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylin…
Olympus Corporation of the Americas
VITROS 350 Chemistry System, clinical chemistry analyzer
Ortho Clinical Diagnostics
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Produc…
Bard Peripheral Vascular Inc
Maxim Laser Projection Series
Gk Photonics Inc
Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycl…
Fresenius Medical Care Renal Therapies Group, LLC
Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient us…
Siemens Medical Solutions USA, Inc
MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant S…
MED-EL Elektromedizinische Gereate, Gmbh
VITROS 5600 Integrated System, clinical chemistry analyzer
Ortho Clinical Diagnostics
Atom Laser Projection Series
Gk Photonics Inc
Ingenuity Core Model # 728321, computed tomography x-ray system
Philips Medical Systems (Cleveland) Inc
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialys…
Medical Components, Inc dba MedComp
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tens…
SenTec AG
CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
Centurion Medical Products Corporation
STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagno…
Centurion Medical Products Corporation
Vereos PET/CT Model # 882446, computed tomography x-ray system
Philips Medical Systems (Cleveland) Inc
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their c…
Opternative Inc
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for …
Abbott Ireland Diagnostics Division
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient …
Medline Industries Inc
IQon Spectral CT Model # 728332, computed tomography x-ray system
Philips Medical Systems (Cleveland) Inc
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
St Jude Medical Inc.
Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient…
Siemens Medical Solutions USA, Inc
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Ortho Clinical Diagnostics
ClubMax Laser Projection Series
Gk Photonics Inc
Spectrum Laser Projection Series
Gk Photonics Inc
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory…
Biomet 3i, LLC
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) -…
Bard Peripheral Vascular Inc
Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to prote…
Burlington Medical, LLC
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or …
Hycor Biomedical Inc
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patien…
Xhale Assurance, Inc.
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondar…
Burlington Medical, LLC
Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF1…
Burlington Medical, LLC
Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed to protect …
Burlington Medical, LLC
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Philips Medical Systems Nederlands
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Burlington Medical, LLC
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic ima…
Agfa N.V.
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVE…
Burlington Medical, LLC
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Terumo Cardiovascular Systems Corporation
2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFV…
Burlington Medical, LLC
Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REE…
Burlington Medical, LLC
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within th…
Terumo Cardiovascular Systems Corporation
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.