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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Aug 14, 2024
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
FDA (openFDA device enforcement)
Reported Aug 14, 2024
NavaClick Syringe and Needle, Model Number LIN02
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Lineage Biomedical, Inc.
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Aug 14, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W.L. Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Mishima K.K.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson Infusion Therapy Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Aug 7, 2024
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio…
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 Aug 7, 2024
SlideView VS200 slide viewer,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Evident Scientific Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medivance Inc.
FDA (openFDA device enforcement)
Reported Aug 7, 2024
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Jul 31, 2024
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
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.