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 6, 2022
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diagnos Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Hanger-Bar 2P 45cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Human Care USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Illumina, Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.InfuTronix LLC
FDA (openFDA device enforcement)
Reported Apr 6, 2022
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mevion Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RaySearch America Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Molecular Systems, Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.ROi CPS LLC
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
EasyFuse Dynamic Compression System Instrument Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
FDA (openFDA device enforcement)
Reported Mar 30, 2022
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ace Surgical Supply Co., Inc.
FDA (openFDA device enforcement)
Reported Mar 30, 2022
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Compella Bariatric Bed System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 30, 2022
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
3 more products 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.