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 169 of 808
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR…
Landauer
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Medtronic Sofamor Danek USA Inc
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microST…
Landauer
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f…
Advance Medical Designs, Inc.
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR…
Landauer
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Keystone Industries
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimeter used with the microSTAR rea…
Landauer
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 04224-KIT; c) 04224-SET; radiation monitoring dosim…
Landauer
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; radiation monitoring dosimeter us…
Landauer
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microST…
Landauer
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; radiation monitoring dosimeter used with the microS…
Landauer
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR…
Landauer
Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse gener…
Abbott Medical
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to …
Abbott Medical
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Remel, Inc
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
Landauer
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Mallinckrodt Manufacturing LLC
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Microbiologics Inc
procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, …
Advance Medical Designs, Inc.
Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the mic…
Landauer
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosim…
Landauer
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed …
Abbott Medical
nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR…
Landauer
NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30…
Landauer
ISee Ortho-K Lens
PARAGON VISION SCIENCES, Inc
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-…
Aomori Olympus Co., Ltd.
Allura Xper series
Philips Medical Systems Nederland B.V.
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Zimmer, Inc.
ZVU Functional GI Software, REF: ZVU-3
Diversatek Healthcare
Azurion
Philips Medical Systems Nederland B.V.
Fargo Ortho-K Lens
PARAGON VISION SCIENCES, Inc
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Philips Ultrasound, Inc.
Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-…
Aomori Olympus Co., Ltd.
MultiDiagnost-Eleva
Philips Medical Systems Nederland B.V.
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Re…
Cook Vandergrift, Inc.
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Aesculap Implant Systems LLC
Emporia Recalls North America Smart Plugs Due to Electric Shock Hazard
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC…
Central Admixture Pharmacy Services, Inc.
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Olympus Corporation of the Americas
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Siemens Healthcare Diagnostics Inc
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…
Datascope Corp.
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model numbe…
Cardiac Assist, Inc
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…
Datascope Corp.
Oculus Pentacam AXL , Ref 70100, CE 0123
Oculus Optikgeraete GMBH
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium …
Siemens Healthcare Diagnostics, Inc.
Olympus Bronchovideoscope, Models BF-3C160.
Olympus Corporation of the Americas
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Olympus Corporation of the Americas
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and pl…
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 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.