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 May 25, 2022
Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Total Resources Intl
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 25, 2022
Turbett Surgical Container, TS1500
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Turbett Surgical, LLC
FDA (openFDA device enforcement)
Reported May 25, 2022
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
FDA (openFDA device enforcement)
Reported May 18, 2022
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
VITEK 2 Systems and VITEK 2 with MYLA.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
FDA (openFDA device enforcement)
Reported May 18, 2022
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cerapedics, Inc.
FDA (openFDA device enforcement)
Reported May 18, 2022
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Certified Safety Mfg Inc.
FDA (openFDA device enforcement)
Reported May 18, 2022
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Daavlin Distributing Company
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
FDA (openFDA device enforcement)
Reported May 18, 2022
HemosIL ReadiPlasTin, Part No. 0020301400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
FDA (openFDA device enforcement)
Reported May 18, 2022
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
11 more products in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
Accula SARS-CoV-2 Test, REF: COV4100
High riskUsing this product could cause serious injury, illness or death — stop using it now.Mesa Biotech, Inc.
FDA (openFDA device enforcement)
Reported May 18, 2022
TMJ Arthroscopy Drape, 85''x 96''
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microtek Medical Inc.
FDA (openFDA device enforcement)
Reported May 18, 2022
BF-MP60: OES Bronchofiberscope
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported May 18, 2022
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Proterixbio
FDA (openFDA device enforcement)
Reported May 18, 2022
Regard brand CABG Pack A and B - Spartanburg
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
FDA (openFDA device enforcement)
Reported May 18, 2022
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shanghai United Imaging Healthcare Co., Ltd.
FDA (openFDA device enforcement)
Reported May 18, 2022
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Simplivia Healthcare Ltd.
FDA (openFDA device enforcement)
Reported May 18, 2022
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
FDA (openFDA device enforcement)
Reported May 18, 2022
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.USA Medical, LLC
FDA (openFDA device enforcement)
Reported May 18, 2022
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
High riskUsing this product could cause serious injury, illness or death — stop using it now.Woodside Acquisitions Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 11, 2022
Restrata, Part Number RWM1-2X2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acera Surgical 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.