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Diagnostic Equipment
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Implants & Prosthetics
(229)
Monitoring Devices
(252)
Diagnostic Equipment
(818)
Home Healthcare
(215)
Contact Lenses & Vision
(17)
Surgical Equipment
(896)
818 recalls
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Qiagen Sciences
Medium Risk
FDA Device
QIAstat-Dx Respiratory Panel Plus Recalled for Risk of False Test Results
Sold in 12 states
Sold at Authorized Medical Distributors, Healthcare Facilities
Recalled
Mar 31, 2025
Added
Mar 21, 2026
Parker Laboratories
Medium Risk
FDA Device
Parker Laboratories, Inc.: Tensive Conductive Adhesive Gel Recalled for Incorrect Viscosity
Sold in 10 states
Sold at Authorized medical distributors
Recalled
Feb 29, 2024
Added
Mar 21, 2026
Medium Risk
FDA Device
Greiner BIO-ONE VACUETTE Coagulation Tubes Recalled for Label Error
Distributed nationwide
Sold at Medical distributors, Laboratories +1 more
504,000 units affected
Recalled
Oct 28, 2025
Added
Mar 21, 2026
Beckman Coulter
Medium Risk
FDA Device
DxI 9000 Access Immunoassay Analyzer Recalled for Incorrect Motor Installation
Distributed nationwide
Sold at Authorized Medical Device Distributors, Direct Sales to Clinical Laboratories
Recalled
Jun 6, 2025
Added
Mar 21, 2026
GE Medical Systems
Medium Risk
FDA Device
Senographe Pristina Mammography Systems Recalled for Incorrect X-Ray Labels
Distributed nationwide
Sold at Medical equipment distributors
Recalled
Dec 9, 2025
Added
Mar 21, 2026
Micro-X
Medium Risk
FDA Device
Rover Mobile X-ray Systems Recalled Due to Potential Tube Failure
Sold in California, New Jersey, Puerto Rico
Sold at Specialty medical distributors
Recalled
Apr 16, 2025
Added
Mar 21, 2026
Medium Risk
FDA Device
Siemens Medical Solutions USA, Inc: Mobilett Mira Mobile X-Ray Systems Recalled for Acoustic Signal Failure
Distributed nationwide
Sold at Siemens Medical Solutions USA, Inc.
Recalled
Nov 14, 2023
Added
Mar 21, 2026
Medium Risk
FDA Device
O-arm O2 Imaging Systems Recalled for Mechanical Component Damage
Sold in Indiana, Minnesota, Mississippi
Sold at Hospital and clinical distributors
Recalled
Jul 9, 2025
Added
Mar 21, 2026
Sheathing Technologies
Medium Risk
FDA Device
Sheathes3D Ultrasound Probe Covers Recalled for Viral Barrier Defects
Sold in Washington
Sold at Medical supply distributors
Recalled
Dec 31, 2025
Added
Mar 21, 2026
Bio-Rad Laboratories
Medium Risk
FDA Device
Bio-Rad Platelia Toxo IgM Assay Kits Recalled for False Positive Risk
Sold in 5 states
Sold at Bio-Rad Laboratories, Inc.
Recalled
Sep 4, 2025
Added
Mar 21, 2026
Hardy Diagnostics
Medium Risk
FDA Device
HardyCHROM CRE Culture Medium Recalled for Quality Control Failure
Sold in 22 states
Sold at Laboratory suppliers, Direct distribution
Klebsiella pneumoniae contamination
Recalled
Jun 27, 2025
Added
Mar 21, 2026
Beckman Coulter
Medium Risk
FDA Device
Beckman Coulter Access 2 Immunoassay Analyzers Recalled for Faulty Sample Motors
Distributed nationwide
Sold at Beckman Coulter, authorized distributors
Recalled
Mar 17, 2025
Added
Mar 21, 2026
Parker Laboratories
Medium Risk
FDA Device
Parker Laboratories, Inc.: Redux Electrolyte Creme Recalled for Low Viscosity
Sold in 15 states
Sold at Medical distributors, Authorized retailers
Recalled
Apr 19, 2024
Added
Mar 21, 2026
Remel
Medium Risk
FDA Device
Remel Campy CVA Medium Recalled for Low Recovery of Campylobacter Jejuni
Sold in 7 states
Sold at Laboratory distributors
Recalled
Feb 26, 2026
Added
Mar 21, 2026
Foundation Medicine
Medium Risk
FDA Device
FoundationOne Diagnostic (F1CDx) Recalled for Incorrect Test Results
Sold in Wisconsin
Sold at Foundation Medicine, Inc.
Recalled
May 30, 2025
Added
Mar 21, 2026
Medium Risk
FDA Device
BD FACSDuet Sample Preparation Systems Recalled for Software Errors
Sold in 13 states
Sold at Direct distribution to clinical and research laboratories
Recalled
Oct 3, 2024
Added
Mar 21, 2026
FUJIFILM Healthcare Americas
Medium Risk
FDA Device
Fujifilm FDR D-EVO2 Mobile X-Ray Systems Recalled for Incorrect Exposure
Distributed nationwide
Sold at FUJIFILM Healthcare Americas Corporation
Recalled
Sep 25, 2024
Added
Mar 21, 2026
Medium Risk
FDA Device
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.: Sterile Ultrasound Gel Recalled Due to Compromised Sterility
Sold in Illinois
Sold at Medline
4,923,471 units affected
Recalled
Jan 20, 2024
Added
Mar 21, 2026
Beckman Coulter
Medium Risk
FDA Device
Beckman Coulter, Inc.: Access Thyroglobulin Calibrators Recalled for Understating Patient Results
Sold at Diagnostic laboratories, Healthcare facilities
Recalled
Oct 11, 2023
Added
Mar 21, 2026
Beckman Coulter
Medium Risk
FDA Device
Beckman Coulter DxI 9000 Immunoassay Analyzers Recalled for Result Delays
Sold in Florida, Texas, Washington
Sold at Beckman Coulter, Inc.
Recalled
Mar 17, 2025
Added
Mar 21, 2026
Radiometer Medical ApS
Medium Risk
FDA Device
Radiometer ABL90 FLEX and FLEX PLUS Analyzers Recalled for Software Freezing
Sold in 48 states
Sold at Radiometer Medical authorized distributors, hospital supply channels
Recalled
Apr 23, 2025
Added
Mar 21, 2026
Quidel
Medium Risk
FDA Device
Quidel Corporation: InflammaDry MMP-9 Tests Recalled for Misaligned Result Windows
Sold in 44 states
Sold at Authorized Medical Distributors
135,440 units affected
Recalled
Apr 24, 2024
Added
Mar 21, 2026
Hermes Medical Solutions AB
Medium Risk
FDA Device
Hermes Hybrid Recon Software Recalled for Incorrect SPECT/CT Image Alignment
Sold in 15 states
Sold at Direct sales, Authorized medical device distributors
Recalled
Dec 12, 2024
Added
Mar 21, 2026
C-RAD POSITIONING AB
Medium Risk
FDA Device
C-RAD Catalyst Radiotherapy Positioning Software Recalled for Rotation Error
Sold in 7 states
Sold at C-RAD POSITIONING AB
Recalled
May 28, 2025
Added
Mar 21, 2026
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