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 Mar 10, 2021
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hamilton Co.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Johnson & Johnson Surgical Vision Inc.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nihon Kohden America Inc.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ReNovo, Inc.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shanghai United Imaging Healthcare Co., Ltd.
FDA (openFDA device enforcement)
Reported Mar 10, 2021
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Infusion Pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Mar 3, 2021
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ecolab Inc.
FDA (openFDA device enforcement)
Reported Mar 3, 2021
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medline Industries Inc.
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Natus Manufacturing Limited
FDA (openFDA device enforcement)
Reported Mar 3, 2021
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Northgate Technologies, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 3, 2021
VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Mar 3, 2021
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Respironics California, LLC
FDA (openFDA device enforcement)
Reported Mar 3, 2021
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Mar 3, 2021
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Silk Road Medical Inc.
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Mar 3, 2021
OT1000 Series Orthopedic Surgical Tables
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
FDA (openFDA device enforcement)
Reported Feb 24, 2021
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2021
BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
FDA (openFDA device enforcement)
Reported Feb 24, 2021
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Feb 24, 2021
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cairn Diagnostics
FDA (openFDA device enforcement)
Reported Feb 24, 2021
IOLMaster 700
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carl Zeiss Meditec AG
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.