Product category · Updated Mar 18, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Category snapshot
Medical Devices accounts for 27,372 recalls — about 32.6% of the 83,949-record federal archive, with 2,343 graded high-severity, most issued by FDA Devices.
- 27,372
- 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 2,343
High severity
2,343 recalls
- Moderate
Moderate
24,310 recalls
- Lower severity 719
Lower severity
719 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
26,000 recalls
- FDA Drug 880
FDA Drug
880 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 51
FDA Food
51 recalls
Recalls in Medical Devices
Newest first · Page 7 of 548
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Merit Medical Systems, Inc.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A,…
RAYSEARCH LABORATORIES AB
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.69…
Tyber Medical
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the si…
Community Products, LLC
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform l…
Edan Diagnostics
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2,…
RAYSEARCH LABORATORIES AB
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and …
Edan Diagnostics
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MH…
LEASEIR TECHNOLOGIES SLU
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Baxter Healthcare Corporation
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Medline Industries, LP
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C…
Merit Medical Systems, Inc.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring …
Edan Diagnostics
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
ICU Medical, Inc.
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Medline Industries, LP
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Ra…
RAYSEARCH LABORATORIES AB
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Merit Medical Systems, Inc.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital sign…
Edan Diagnostics
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description…
MicroPort Orthopedics Inc.
Thrasio Recalls Angry Orange Enzyme Stain Removers Due to Risk of Exposure to Bacteria
Thrasio, LLC, of Boston, Massachusetts
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Elekta, Inc.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Canon Medical System, USA, INC.
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Medline Industries, LP
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Intuitive Surgical, Inc.
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
Allura Xper FD10F; Model Number: 722002;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ5448…
Medline Industries, LP
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Des…
Heraeus Medical GmbH (Dental Division)
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on S…
Medtronic Neuromodulation
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Medicrea International
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC0102…
Medline Industries, LP
Allura Xper FD10/10; Model Number: 722027;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722028;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product Name: Allura Xper FD10C; Model number: 722001;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. A…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Number: 722003;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVI…
Medline Industries, LP
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) P…
Medline Industries, LP
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Mobius Imaging, LLC
Allura Xper FD10/10; Model Number: 722011;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2…
Medline Industries, LP
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
REPLIGEN CORPORATION
Allura Xper FD20/20; Model Number: 722038;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972…
Medline Industries, LP
Allura Xper FD10/10; Model Number: 722005;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722012;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
ICU Medical Inc.
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP …
Medline Industries, LP
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti…
Diagnostica Stago, Inc.
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Gl…
Abbott Diabetes Care, Inc.
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Hologic, 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 Mar 18, 2026.
Read our methodology — how this data is sourced, computed, and verified.
