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 339 of 819
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary in…
Biomet
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Biocare Medical, LLC
Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 def…
Physio-Control, Inc.
Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or li…
Genicon, Inc.
Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or li…
Genicon, Inc.
Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol gr…
Genicon, Inc.
HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by…
Hardy Diagnostics
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, …
Philips Healthcare Informatics, Inc.
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, …
Physio-Control, Inc.
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be u…
RAYSEARCH LABORATORIES AB
STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minim…
Intuitive Surgical, Inc.
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer …
RAYSEARCH LABORATORIES AB
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fix…
Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixa…
Biomet
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determinat…
Siemens Healthcare Diagnostics, Inc.
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./D…
BioFire Diagnostics, LLC
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Elekta Limited
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixa…
Biomet
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determin…
Siemens Healthcare Diagnostics, Inc.
Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol…
Genicon, Inc.
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixa…
Biomet
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with t…
Becton, Dickinson and Company, BD Biosciences
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixa…
Biomet
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stab…
Biomet
Edwards Recalls Mechanical Heat Detectors Due to Failure to Alert to Fire
Republic Wireless Recalls Relay Charging Cables Due to Overheating and Burn Hazards
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary …
Trividia Health, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
PerkinElmer 226 Sample Collection Device
PerkinElmer Health Sciences, Inc.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices i…
Zimmer Biomet, Inc.
AC Powered hospital adjustable bed.
Umano Medical, Inc.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Im…
Beckman Coulter Inc.
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysi…
Baxter Healthcare Corporation
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassa…
Beckman Coulter Inc.
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation devices i…
Zimmer Biomet, Inc.
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Radiometer Medical ApS
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone …
Osteomed, LLC
Pressure Monitoring Set, C-PMS, G02838
Cook Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Syste…
Beckman Coulter Inc.
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Medtronic Inc.
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone dur…
Osteomed, LLC
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Nobel Biocare Usa Llc
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.