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 74 of 810
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): …
Integra LifeSciences Corp.
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crown…
Hiossen Inc.
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prost…
Hiossen Inc.
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-…
Micro Therapeutics, Inc.
BD BBL TB Stain Kit K, Catalog (REF): 212522
Becton Dickinson & Co.
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Kung Shin Plastics Co. Ltd.
Vios Monitoring System Bedside Monitor Model BSM2050
Murata Vios, Inc.
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.…
Medimaps Group
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regu…
Beckman Coulter, Inc.
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Medtronic MiniMed, Inc.
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 8…
Bard Peripheral Vascular Inc
MIM software; System, Image Processing, Radiological
MIM Software Inc
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6…
Kung Shin Plastics Co. Ltd.
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Medtronic MiniMed, Inc.
Paradigm REF: MMT-712 and MMT-715
Medtronic MiniMed, Inc.
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crown…
Hiossen Inc.
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-…
Micro Therapeutics, Inc.
MiniMed insulin pump, REF: 620G (MMT-1750)
Medtronic MiniMed, Inc.
Paradigm insulin pump, REF: MMT-754
Medtronic MiniMed, Inc.
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Medtronic MiniMed, Inc.
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crown…
Hiossen Inc.
ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns…
Hiossen Inc.
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Medtronic MiniMed, Inc.
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Baxter Healthcare Corporation
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Telcare, LLC
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Baxter Healthcare Corporation
MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
Medtronic MiniMed, Inc.
MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Medtronic MiniMed, Inc.
MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
Medtronic MiniMed, Inc.
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis …
LUMENIS, LTD.
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological …
Biosense Webster, Inc.
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Conne…
DeRoyal Industries Inc
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550…
Alcon Research LLC
MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Medtronic MiniMed, Inc.
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
TAS Medical Inc
Philips IntelliSpace Cardiovascular software, Model 830089.
Philips Medical Systems Nederland B.V.
Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prost…
Hiossen Inc.
Black Diamond Equipment Recalls BD Recon LT Avalanche Transceivers Due to Risk of Loss of Emergency Communications; Risk of Serious Injury or Death
Taylor Water Technologies Recalls Phosphate Reagent Bottles Sold with Test Kits Due to Risk of Severe Chemical Burns; Violation of Federal Regulation…
Taylor Water Technologies LLC, of Sparks, Maryland
A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number…
Tyber Medical
A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number:…
Tyber Medical
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
TERRAGENE S.A.
Brivo MR355, NMRI system
GE Healthcare (China) Co., Ltd.
A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Num…
Tyber Medical
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous o…
CareFusion 303, Inc.
A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number:…
Tyber Medical
A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal…
Tyber Medical
A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number…
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to …
Tyber Medical
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.