Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Apr 21, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
VIDAS¿ CMV IgM 30 Tests
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centinel Spine, Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
FDA (openFDA device enforcement)
Reported Apr 21, 2021
The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.EOS Imaging
FDA (openFDA device enforcement)
Reported Apr 21, 2021
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fujifilm Medical Systems U.S.A., Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hubo International Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.K2M, Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Krishe Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.OriGen Biomedical, Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Molecular Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
19 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Apr 21, 2021
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sunstar Americas, Inc.
FDA (openFDA device enforcement)
Reported Apr 21, 2021
MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vectornate USA Inc.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arrow International Inc.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
MicroScan WalkAway-40 plus Instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
1 more product in this recall
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.