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 Jan 1, 2025
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Jan 1, 2025
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
FDA (openFDA device enforcement)
Reported Jan 1, 2025
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Moximed, Inc.
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noah Medical
FDA (openFDA device enforcement)
Reported Jan 1, 2025
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nova Biomedical Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Moderate riskThis product could cause temporary or reversible health problems — stop using it.O&m Halyard, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Seaspine Orthopedics Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straight Smile, LLC
FDA (openFDA device enforcement)
Reported Jan 1, 2025
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Augustine Temperature Management, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Kirwan Surgical Products, LLC
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MicroPort Orthopedics Inc.
FDA (openFDA device enforcement)
Reported Dec 25, 2024
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mint Medical GmbH
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Galaxy System (GAL-001)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noah Medical
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Duravent Silicone Ventilation Tube. Model Number: 240075.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Ltd.
1 more product 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.