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 Jun 14, 2023
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Mechatronics USA
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
FDA (openFDA device enforcement)
Reported Jun 14, 2023
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Young Dental Manufacturing I, LLC
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytrellis Biosystems, Inc.
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported Jun 7, 2023
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
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 Jun 7, 2023
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Linkbio Corp.
FDA (openFDA device enforcement)
Reported Jun 7, 2023
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Intelli-C, Right side suspended Tabletop, REF: 03400000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nrt X-Ray A/s
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2023
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
Reported Jun 7, 2023
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex LLC
FDA (openFDA device enforcement)
Reported Jun 7, 2023
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Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trophy SAS
FDA (openFDA device enforcement)
Reported May 31, 2023
Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arjohuntleigh Magog, Inc.
FDA (openFDA device enforcement)
Reported May 31, 2023
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Berlin Heart GmbH
FDA (openFDA device enforcement)
Reported May 31, 2023
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Binx Health, Inc.
FDA (openFDA device enforcement)
Reported May 31, 2023
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported May 31, 2023
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2023
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OmniCell, 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.