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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Jan 8, 2025
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
FDA (openFDA device enforcement)
Reported Jan 8, 2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2025
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carwild Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2025
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Med Michigan Holding LLC
FDA (openFDA device enforcement)
Reported Jan 8, 2025
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
FDA (openFDA device enforcement)
Reported Jan 1, 2025
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
FDA (openFDA device enforcement)
Reported Jan 1, 2025
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Vascular Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jan 1, 2025
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Bio Sciences
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Braemar Manufacturing, LLC
FDA (openFDA device enforcement)
Reported Jan 1, 2025
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
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)
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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.