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 Jul 5, 2023
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
High riskUsing this product could cause serious injury, illness or death — stop using it now.Megadyne Medical Products, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Permobil
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Phadia US Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
DigitalDiagnost C90, Model No. 712034 and 712035
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Randox Laboratories Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RaySearch America Inc.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex LLC
122 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
ARROW Endurance Extended Dwell Peripheral Catheter System
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
FDA (openFDA device enforcement)
Reported Jun 28, 2023
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Jun 28, 2023
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
FDA (openFDA device enforcement)
Reported Jun 28, 2023
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Helena Laboratories, Corp.
FDA (openFDA device enforcement)
Reported Jun 28, 2023
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Illumina, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Masimo Corporation
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Jun 28, 2023
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
119 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SenTec AG
FDA (openFDA device enforcement)
Reported Jun 28, 2023
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilson-Cook Medical Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Total Knee Pack, REF CETJ130, medical convenience kits
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.American Contract Systems, 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.