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 78 of 808
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
New Medical Technologies Gmbh
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate ca…
Belmont Instrument LLC
Allura Xper FD20/20 System Code: (1) 722038
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1…
Nobel Biocare
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT …
Neilmed Pharmaceuticals Inc
Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Discovery XR656HD. X-Ray imaging system.
GE Medical Systems, LLC
Temporary Titanium Abutments
DDS Lab
IntelliBridge EC10 Module. Model Number: 865115
Philips North America Llc
AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligat…
Ethicon, LLC
Allura Xper FD10C System Code: (1) 722001
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
LIFEPAK 35 ECG cable REF 11111-000041
Physio-Control, Inc.
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting,…
Sysmex America, Inc.
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Boston Scientific Corporation
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Karl Storz Endoscopy
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
MEDLINE INDUSTRIES, LP - Northfield
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Karl Storz Endoscopy
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Boston Scientific Corporation
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
MEDLINE INDUSTRIES, LP - Northfield
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Refere…
Medtronic Navigation, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Zimmer, Inc.
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Boston Scientific Corporation
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
MEDLINE INDUSTRIES, LP - Northfield
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Karl Storz Endoscopy
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
MEDLINE INDUSTRIES, LP - Northfield
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The Cy…
Accuray Incorporated
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Boston Scientific Corporation
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Karl Storz Endoscopy
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 ar…
CareFusion 303, Inc.
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Boston Scientific Corporation
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and n…
Draeger Medical Systems, Inc.
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Boston Scientific Corporation
ARTIS One Angiographic X-Ray System
SIEMENS MEDICAL SOLUTIONS USA, INC
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC0…
MEDLINE INDUSTRIES, LP - Northfield
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Boston Scientific Corporation
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Instrumentation Laboratory
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
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.