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 Mar 2, 2022
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Feb 23, 2022
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Base 10 Genetics Inc.
FDA (openFDA device enforcement)
Reported Feb 23, 2022
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Envisiontec US LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hill-Rom, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merete Medical GmbH
FDA (openFDA device enforcement)
Reported Feb 23, 2022
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Feb 23, 2022
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Destino Twist 14F (also branded as Guidestar 14F)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oscor Inc.
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Zenition 50, Model #718096
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
FDA (openFDA device enforcement)
Reported Feb 16, 2022
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
10 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 16, 2022
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 16, 2022
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.E25Bio, Inc.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
31 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gentueri Inc.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mallinckrodt Pharmaceuticals Ireland Ltd.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
CURAD REUSABLE GEL HOT/COLD PACK
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
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.