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 8 of 548
FDA Devices Moderate Jan 21, 2026
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Canon Medical System, USA, INC.
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20/10; Model Number: 722029;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) A…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
SMV DSI, System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
FDA Devices Moderate Jan 21, 2026
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Fresenius Kabi USA, LLC
FDA Devices Moderate Jan 21, 2026
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Mobius Imaging, LLC
FDA Devices Moderate Jan 14, 2026
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Vision RT Ltd
FDA Devices Moderate Jan 14, 2026
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is requir…
Integra LifeSciences Corp. (NeuroSciences)
FDA Devices Moderate Jan 14, 2026
Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
FDA Devices Moderate Jan 14, 2026
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-…
CareFusion 303, Inc.
FDA Devices Moderate Jan 14, 2026
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
FDA Devices Moderate Jan 14, 2026
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Applied Medical Resources Corp
FDA Devices Moderate Jan 14, 2026
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB S…
Medline Industries, LP
FDA Devices Moderate Jan 14, 2026
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
FDA Devices Moderate Jan 14, 2026
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
FDA Devices Critical Jan 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
AVID Medical, Inc.
FDA Devices Critical Jan 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
AVID Medical, Inc.
FDA Devices Moderate Jan 14, 2026
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 1138…
IMRIS Imaging Inc
FDA Devices Moderate Jan 14, 2026
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Meridian Bioscience Inc
FDA Devices Moderate Jan 14, 2026
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. …
Remote Diagnostic Technologies Ltd.
FDA Devices Moderate Jan 14, 2026
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Siemens Medical Solutions USA, Inc
CPSC Moderate Jan 8, 2026
Isla Rae Magnetic Wireless Chargers Recalled Due to Fire and Burn Hazards; Sold by TJX at T.J. Maxx and Marshalls Stores
The TJX Companies Inc., of Framingham, Massachusetts
FDA Devices Moderate Jan 7, 2026
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Beaver-Visitec International, Inc.
FDA Devices Moderate Jan 7, 2026
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Vortex Surgical Inc.
FDA Devices Moderate Jan 7, 2026
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF…
Philips Ultrasound, LLC
FDA Devices Moderate Jan 7, 2026
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial…
Ferndale Laboratories, Inc.
FDA Devices Moderate Jan 7, 2026
Material Processing Laser Products
SHENZHEN ATOMSTACK TECHNOLOGIES
FDA Devices Moderate Jan 7, 2026
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, …
Sheathing Technologies Inc
FDA Devices Moderate Dec 31, 2025
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-…
CareFusion 303, Inc.
FDA Devices Moderate Dec 31, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900…
Medtronic Neuromodulation
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
ICU Medical, Inc.
FDA Devices Moderate Dec 31, 2025
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diod…
Howmedica Osteonics Corp.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: …
Zimmer, Inc.
FDA Devices Critical Dec 31, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Draeger, Inc.
FDA Devices Moderate Dec 31, 2025
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-…
Cook Incorporated
FDA Devices Moderate Dec 31, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Microbiologics Inc
FDA Devices Moderate Dec 31, 2025
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Diasol, Inc
FDA Devices Moderate Dec 31, 2025
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Diasol, Inc
FDA Devices Moderate Dec 31, 2025
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Diasol, Inc
FDA Devices Moderate Dec 31, 2025
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Intuitive Surgical, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
ICU Medical, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: …
Zimmer, 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.
