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
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 52 of 810
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 01…
Boston Scientific Corporation
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA sys…
Dynex Technologies, Inc.
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare profes…
Immunotech A.S.
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Diversatek Healthcare
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applica…
SPINEART SA
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Baxter Healthcare Corporation
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-2…
Insightra Medical Inc
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Descriptio…
Encore Medical, LP
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model…
Carefree Surgical Specialties
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Descriptio…
Encore Medical, LP
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Ro…
Carefree Surgical Specialties
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, …
Ambu Inc.
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Spark Biomedical Inc
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current L…
Trinity Biotech USA
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Instrumentation Laboratory
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Philips Respironics, Inc.
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Boston Scientific Corporation
DreamStation Auto. Non-Continuous Ventilator.
Philips Respironics, Inc.
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK …
CareFusion 303, Inc.
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model…
Carefree Surgical Specialties
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applica…
SPINEART SA
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The …
Thoratec LLC
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
GE Medical Systems, LLC
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Waldemar Link GmbH & Co. KG (Mfg Site)
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, …
Merit Medical Systems, Inc.
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes M…
Carefree Surgical Specialties
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
DreamStation Auto CPAP. Non-Continuous Ventilator.
Philips Respironics, Inc.
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Merit Medical Systems, Inc.
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Merit Medical Systems, Inc.
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 …
Boston Scientific Corporation
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Waldemar Link GmbH & Co. KG (Mfg Site)
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, 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 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.