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 May 22, 2024
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wishbone Medical, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
14 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 15, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, SCS
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hologic, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nrt X-Ray A/s
FDA (openFDA device enforcement)
Reported May 15, 2024
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38…
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 May 15, 2024
PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spineart Sa
FDA (openFDA device enforcement)
Reported May 15, 2024
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
FDA (openFDA device enforcement)
Reported May 15, 2024
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
High riskUsing this product could cause serious injury, illness or death — stop using it now.Tandem Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical, Inc.
FDA (openFDA device enforcement)
Reported May 8, 2024
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
FDA (openFDA device enforcement)
Reported May 8, 2024
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Instruments, LLC
FDA (openFDA device enforcement)
Reported May 8, 2024
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Research Medical, LLC
FDA (openFDA device enforcement)
Reported May 8, 2024
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alere San Diego, Inc.
FDA (openFDA device enforcement)
Reported May 8, 2024
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Allergan Sales, LLC
FDA (openFDA device enforcement)
Reported May 8, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
FDA (openFDA device enforcement)
Reported May 8, 2024
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Innomed, Inc.
FDA (openFDA device enforcement)
Reported May 8, 2024
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent Ag
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision, 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.