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 396 of 819
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
Bard Peripheral Vascular Inc
Quantum Pump Console
Spectrum Medical Ltd.
Monaco Radiation Treatment Planning System (RTP) System
Elekta, Inc.
EyeBOX Model OCL 02
OCULOGICA
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
Roche Diagnostics Operations, Inc.
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnost…
Phadia Ab
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801…
Bard Peripheral Vascular Inc
MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage…
Agilent Technologies, Inc.
Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is…
Stryker GmbH
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
Bard Peripheral Vascular Inc
Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number …
Siemens Medical Solutions USA, Inc
The Beaufort Bonnet Company Recalls Handmade Knit Dolls Due to Injury Hazard
GreatCall Recalls Lively Mobile Plus Emergency Alert Device Due to Risk of Call Button Failing in an Emergency (Recall Alert)
Borqs Hong Kong Limited
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Edwards Lifesciences, LLC
Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
Becton Dickinson & Co.
Microdot Xtra blood glucose test strips
Cambridge Sensors Limited
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) U…
Thoratec Corp.
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
Becton Dickinson & Company
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purificati…
Qiagen Sciences LLC
BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
Becton Dickinson & Company
Kit BD Max StaphSR; Catalog # 443418
Becton Dickinson & Co.
BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
Becton Dickinson & Company
Kit BD Max ExK DNA 1 USA; Catalog # 442817
Becton Dickinson & Co.
Kit EXT Enteric Bacterial Panel; Catalog # 443812
Becton Dickinson & Co.
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Becton Dickinson & Co.
Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator Us…
Arcos, Inc
BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
Becton Dickinson & Company
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A…
Siemens Medical Solutions USA, Inc.
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Aniara Diagnostica LLC
Kit BD Max Enteric Viral Panel EU Catalog # 443985
Becton Dickinson & Co.
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
Becton Dickinson & Company
MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Siemens Medical Solutions USA, Inc
BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
Becton Dickinson & Company
Kit BD Max ExK TNA 2; Catalog # 442825
Becton Dickinson & Co.
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Edwards Lifesciences, LLC
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
Becton Dickinson & Co.
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 …
Pro-Dex Inc
Kit BD Max MRSA; Catalog # 442953
Becton Dickinson & Co.
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Siemens Healthcare Diagnostics, Inc.
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, V…
Siemens Medical Solutions USA, Inc.
Kit BD Max Vaginal Panel; Catalog # 443712
Becton Dickinson & Co.
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
Becton Dickinson & Co.
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling…
Luminex Corporation
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Siemens Medical Solutions USA, Inc
Kit BD Max StaphSR; Catalog # 443419
Becton Dickinson & Co.
BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
Becton Dickinson & Company
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA…
Siemens Medical Solutions USA, Inc.
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11…
Siemens Medical Solutions USA, 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.