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 May 29, 2024
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Channel Medsystems, Inc.
FDA (openFDA device enforcement)
Reported May 29, 2024
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
FDA (openFDA device enforcement)
Reported May 29, 2024
Blood Pump Rotor, Model Number: F40015481 Rev A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported May 29, 2024
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported May 29, 2024
Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Jiangsu Shenli Medical Production Co., Ltd.
86 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported May 29, 2024
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.OptumHealth Care Solutions LLC
FDA (openFDA device enforcement)
Reported May 29, 2024
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
31 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
BiPAP V30 Auto Ventilator, Part Number 1111178
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
FDA (openFDA device enforcement)
Reported May 29, 2024
Stryker Blueprint Software, Catalog #BPUE001.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier S.A.S.
FDA (openFDA device enforcement)
Reported May 29, 2024
Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Yamaha Motor Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Andover Healthcare Inc.
FDA (openFDA device enforcement)
Reported May 22, 2024
Spectrum IQ Infusion pump, Product Code 357009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
47 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported May 22, 2024
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Medical Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher & Paykel Healthcare, Ltd.
FDA (openFDA device enforcement)
Reported May 22, 2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported May 22, 2024
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported May 22, 2024
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
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.