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 Nov 6, 2024
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Westmed, Inc.
FDA (openFDA device enforcement)
Reported Oct 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ad-Tech Medical Instrument Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B-K Medical A/S
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Blue Ortho
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex-Ohmeda, Inc.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Diasol Acid Concentrate REF G100325-10Dex 100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasol, Inc.
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
FDA (openFDA device enforcement)
Reported Oct 30, 2024
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
33 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and…
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 Oct 30, 2024
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Oct 30, 2024
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
FDA (openFDA device enforcement)
Reported Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
23 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectrum Medical Ltd.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
21 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cue Health Inc.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
GE Heathcare Giraffe OmniBed; neo natal incubator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex--Ohmeda, Inc.
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.