Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 810
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Beckman Coulter, Inc.
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXperFD20/15 System Code: (1) 722058
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Beckman Coulter Inc.
Azurion 5 M12 System Code: (1) 722227 (2) 722231
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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 Jun 3, 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 Jun 3, 2026.