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 Dec 13, 2023
RANDOX Total Bilirubin.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Remington MEDICAL Drainage Bag, REF 600-D;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remington Medical, Inc.
FDA (openFDA device enforcement)
Reported Dec 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Staar Surgical Company
10 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stanbio Laboratory, LP
FDA (openFDA device enforcement)
Reported Dec 13, 2023
ProCuity bed series, model number 3009, item number: 300900000000,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
12 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thor Photomedicine Ltd.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vyaire Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilson-Cook Medical Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 6, 2023
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Dec 6, 2023
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aizu Olympus Co., Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 6, 2023
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson Infusion Therapy Systems Inc.
FDA (openFDA device enforcement)
Reported Dec 6, 2023
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Breas Medical, Inc.
FDA (openFDA device enforcement)
Reported Dec 6, 2023
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edwards Lifesciences, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 6, 2023
Lugol s Iodine Solution 500ML, Part Number 624-71
Moderate riskThis product could cause temporary or reversible health problems — stop using it.EMD Millipore Corporation
FDA (openFDA device enforcement)
Reported Dec 6, 2023
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Dec 6, 2023
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Dec 6, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Path
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 6, 2023
RAPIDPOINT 500e Blood Gas System
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 Nov 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aizu Olympus Co., Ltd.
21 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
FDA (openFDA device enforcement)
Reported Nov 29, 2023
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
18 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2023
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
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.