Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 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 135 of 808
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to …
Cook Incorporated
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Masimo Corporation
Ingenia Elition X, Magnetic Resonance System.
Philips North America Llc
Enterprise 1.5T, Magnetic Resonance System.
Philips North America Llc
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE P…
Cook Incorporated
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications …
Cook Incorporated
MR 7700, Magnetic Resonance System.
Philips North America Llc
GYROSCAN T5, Magnetic Resonance System.
Philips North America Llc
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Philips North America Llc
Achieva 3.0TX for PET, Magnetic Resonance System.
Philips North America Llc
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) …
Smiths Medical ASD Inc.
Intera CV, Magnetic Resonance System.
Philips North America Llc
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics, Inc.
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Masimo Corporation
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purp…
Siemens Medical Solutions USA, Inc
Achieva 1.5T Conversion, Magnetic Resonance System.
Philips North America Llc
Intera 1.5T R11, Magnetic Resonance System.
Philips North America Llc
Achieva 1.5T Initial, Magnetic Resonance System.
Philips North America Llc
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular appli…
Cook Incorporated
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Philips North America Llc
Evolution Upgrade 3.0T, Magnetic Resonance System.
Philips North America Llc
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. P…
Smith & Nephew Medical, Ltd.
SmartPath to dStream for 1.5T, Magnetic Resonance System.
Philips North America Llc
Achieva 3.0T for PET, Magnetic Resonance System.
Philips North America Llc
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 9117…
Elekta Instrument AB
MR 5300, Magnetic Resonance System.
Philips North America Llc
Ingenia Ambition X, Magnetic Resonance System.
Philips North America Llc
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics, Inc.
Intera 1.5T Power/Pulsar, Magnetic Resonance System.
Philips North America Llc
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Philips Respironics, Inc.
Intera 0.5T Standard, Magnetic Resonance System.
Philips North America Llc
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics, Inc.
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Artivion, Inc
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
Philips North America Llc
Ingenia 1.5T, Magnetic Resonance System.
Philips North America Llc
Dr¿ger Perseus A500 Anesthesia Workstation
Draeger Medical, Inc.
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Smiths Medical ASD Inc.
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS …
Ethicon, Inc.
GYROSCAN T10-NT, Magnetic Resonance System.
Philips North America Llc
Intera 3.0T Quasar Dual, Magnetic Resonance System.
Philips North America Llc
Ingenia 3.0T, Magnetic Resonance System.
Philips North America Llc
Ingenia Ambition S, Magnetic Resonance System.
Philips North America Llc
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va…
Cook Incorporated
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Pr…
Smith & Nephew Medical, Ltd.
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05…
Cook Incorporated
SW Bari Lift & Transfer, Model Number 38060000
Raye's Inc.
Intera 1.5T Master/Nova, Magnetic Resonance System.
Philips North America Llc
Ingenia 3.0T CX, Magnetic Resonance System.
Philips North America Llc
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who…
Boston Scientific Corporation
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Fresenius Kabi 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 2, 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 2, 2026.