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 · 2026-08-25
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 527 of 819
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiol…
Merge Healthcare, Inc.
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111…
EOS Imaging
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and record…
Merge Healthcare, Inc.
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Smith & Nephew, Inc.
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent…
Euro Diagnostica AB
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Shimadzu Medical Systems Usa Com
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of su…
Intuitive Surgical, Inc.
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Onkos Surgical, Inc.
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator…
Medtest Holdings, Inc.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Beckman Coulter Inc.
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to in…
DeRoyal Industries Inc
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of mul…
Mindray DS USA, Inc. dba Mindray North America
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure…
AGFA Healthcare Corp.
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
CryoLife, Inc.
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V…
3M Company - Health Care Business
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventi…
Exactech, Inc.
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the w…
Shimadzu Medical Systems Usa Com
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Onkos Surgical, Inc.
Access Thyroglobulin, A34085G, Catalog No. 33860
Beckman Coulter Inc.
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workfl…
Elekta, Inc.
Access Total T3, A34435H, Catalog No. 33830
Beckman Coulter Inc.
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Medtest Holdings, Inc.
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge …
Merge Healthcare, Inc.
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-…
Carestream Health Inc
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urologi…
Olympus Corporation of the Americas
Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amou…
Covidien LLC
LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71…
Smith & Nephew, Inc.
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, m…
Merge Healthcare, Inc.
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a …
Merge Healthcare, Inc.
SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ra…
Shimadzu Medical Systems Usa Com
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use…
Medtest Holdings, Inc.
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Beckman Coulter Inc.
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulev…
Z-Medica, LLC
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex h…
Abbott Laboratories
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurr…
DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent …
DePuy Mitek, Inc., a Johnson & Johnson Co.
Merge OrthoPACS software.
Merge Healthcare, Inc.
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Siemens Healthcare Diagnostics, Inc.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent sh…
DePuy Mitek, Inc., a Johnson & Johnson Co.
MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
Medtronic Inc.
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Medtronic Inc.
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
Medtronic Inc.
DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recu…
DePuy Mitek, Inc., a Johnson & Johnson Co.
Proteus 235
Ion Beam Applications S.A.
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. Th…
Vascular Solutions, Inc.
Dimension Vista Prolactin (PRL) Flex reagent cartridge
Siemens Healthcare Diagnostics, Inc.
DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat re…
DePuy Mitek, Inc., a Johnson & Johnson Co.
Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare prof…
Omega Medical Imaging, Inc.
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
Medtronic Inc.
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, 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.