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 Dec 14, 2022
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Dec 14, 2022
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Insulet Corporation
FDA (openFDA device enforcement)
Reported Dec 14, 2022
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integrity Implants Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2022
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intersect ENT, Inc.
FDA (openFDA device enforcement)
Reported Dec 14, 2022
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medacta USA Inc.
FDA (openFDA device enforcement)
Reported Dec 14, 2022
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Dec 14, 2022
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 14, 2022
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2022
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qvella Corporation
FDA (openFDA device enforcement)
Reported Dec 14, 2022
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2022
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
High riskUsing this product could cause serious injury, illness or death — stop using it now.Remel Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2022
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Dec 7, 2022
Accelerate PhenoTest BC kit REF 10101018
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accelerate Diagnostics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2022
Alcon Custom Pak Surgical Procedure Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
FDA (openFDA device enforcement)
Reported Dec 7, 2022
CMV IgM EIA, in vitro diagnostic.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Dec 7, 2022
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Busse Hospital Disposables, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2022
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cytocell Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2022
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greer Laboratories, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2022
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GS Biomark LLC
FDA (openFDA device enforcement)
Reported Dec 7, 2022
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Dec 7, 2022
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mobius Imaging, LLC
FDA (openFDA device enforcement)
Reported Dec 7, 2022
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Owens & Minor Distribution, Inc.
FDA (openFDA device enforcement)
Reported Dec 7, 2022
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Primus Corporation dba Trinity Biotech
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 30, 2022
3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Healthcare Business
17 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.