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 · 2026-09-02
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 725 of 822
Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such …
Davol, Inc., Subs. C. R. Bard, Inc.
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications …
Bayer Corp
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of t…
Hologic, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, su…
Davol, Inc., Subs. C. R. Bard, Inc.
Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the bo…
Siemens Medical Solutions USA, Inc
Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as t…
Davol, Inc., Subs. C. R. Bard, Inc.
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitr…
Leica Microsystems, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies,…
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, su…
Davol, Inc., Subs. C. R. Bard, Inc.
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (tou…
Stryker Instruments Div. of Stryker Corporation
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography syst…
Hologic, Inc.
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
Hospira Inc.
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
Siemens Medical Solutions USA, Inc
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, co…
Siemens Medical Solutions USA, Inc
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determinat…
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determinatio…
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro dia…
Siemens Healthcare Diagnostics, Inc
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professiona…
GE Healthcare
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
B. Braun Medical, Inc.
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diag…
Siemens Healthcare Diagnostics, Inc
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digit…
AGFA Corp.
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling B…
Synthes, Inc.
Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liqu…
Beaver-Visitec International Inc.
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with …
Medtronic Inc. Cardiac Rhythm Disease Management
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Physio-Control, Inc.
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer.…
Abbott Laboratories
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Siemens Medical Solutions USA, Inc.
ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnost…
Siemens Healthcare Diagnostics, Inc
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Siemens Medical Solutions USA, Inc.
ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination o…
Siemens Healthcare Diagnostics, Inc
ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stab…
Abbott Laboratories
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, …
The Anspach Effort, Inc.
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 …
Smith & Nephew Inc
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Fujifilm Medical System USA, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a p…
Smiths Medical ASD, Inc.
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical ar…
Heraeus Kulzer, LLC.
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system t…
Philips Healthcare Informatics, Inc.
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/EC…
Ortho-Clinical Diagnostics
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Mo…
Terumo Cardiovascular Systems Corporation
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic ren…
Gambro Renal Products, Incorporated
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Sy…
Hospira Inc.
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the rel…
GE Healthcare, LLC
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central c…
Arrow International Inc
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended …
Microline Surgical
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 716…
Smith & Nephew Inc
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in h…
Siemens Healthcare Diagnostics, Inc.
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generat…
Philips Medical Systems, Inc.
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nomina…
Hospira Inc.
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; H…
Hospira 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 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.