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 Jun 5, 2024
BD Pyxis MedStation ES, REF: 323, Medication Cabinet
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
FDA (openFDA device enforcement)
Reported Jun 5, 2024
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lucid Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mirion Technologies (Capintec), Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Reflexion Medical, Inc.
FDA (openFDA device enforcement)
Reported Jun 5, 2024
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Orthopaedics
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
FDA (openFDA device enforcement)
Reported May 29, 2024
Cascade IOMAX Cortical Module, REF: 190296-200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cadwell Industries Inc.
FDA (openFDA device enforcement)
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)
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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.