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 353 of 819
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Medtronic MiniMed
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Abbott Diabetes Care, Inc.
Imager II 5F Angiographic Catheters, 5 units per package.
Boston Scientific Corporation
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicate…
Dexcom Inc
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
Skytron, Div. The KMW Group, Inc
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Techn…
Capintec Inc
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-…
Abbott Gmbh & Co. KG
BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Prod…
Bard Peripheral Vascular Inc
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
Medtronic MiniMed
1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port…
Bard Peripheral Vascular Inc
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device…
Dexcom Inc
iChemVELOCITY Strips, Catalog 800-7212
Beckman Coulter, Inc.
PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438…
Bard Peripheral Vascular Inc
MiniMed Insulin Pump, model # MMT-508
Medtronic MiniMed
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicate…
Dexcom Inc
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
MEDTRONIC ATS MEDICAL, INC.
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
Medtronic MiniMed
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-…
Insulet Corporation
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
Karl Storz Endoscopy
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the qualit…
Randox Laboratories Ltd.
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
Medtronic MiniMed
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Su…
QUIDEL CARDIOVASCULAR INC
MiniMed Paradigm 512 Insulin pump
Medtronic MiniMed
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use i…
Siemens Healthcare Diagnostics, Inc.
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: B…
Bard Peripheral Vascular Inc
BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usa…
Bard Peripheral Vascular Inc
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
Carroll-Baccari, Inc.
MiniMed Paradigm Insulin pump, model number MMT-712
Medtronic MiniMed
FlipCutter III Drill
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: D…
Siemens Healthcare Diagnostics, Inc.
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RaySta…
RAYSEARCH LABORATORIES AB
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 ass…
Siemens Healthcare Diagnostics, Inc.
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Medtronic MiniMed
MiniMed Paradigm Model 511 Insulin Pump
Medtronic MiniMed
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Abbott Diabetes Care, Inc.
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)008…
Bard Peripheral Vascular Inc
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
Medtronic MiniMed
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Medline Industries Inc
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and del…
Elekta Impac Software
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE…
Fresenius Medical Care Holdings, Inc.
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Siemens Healthcare Diagnostics, Inc.
1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)008017410…
Bard Peripheral Vascular Inc
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
Medtronic MiniMed
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Carroll-Baccari, Inc.
1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are in…
Bard Peripheral Vascular Inc
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
Karl Storz Endoscopy
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Abbott Diabetes Care, Inc.
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741…
Bard Peripheral Vascular Inc
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in t…
Siemens Healthcare Diagnostics, 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.