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 18, 2025
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quantum Surgical Sas
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tecfen Medical
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Turncare, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zyno Medical LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Mishima K.K.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Access Testosterone assay, Catalog Number 33560
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Civco Medical Instruments Co. Inc.
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dexcom, Inc.
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Flux Technology Inc.
FDA (openFDA device enforcement)
Reported Jun 11, 2025
FoundationOne Companion Diagnostic (F1CDx)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Foundation Medicine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healthmark Industries Co., Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU…
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 11, 2025
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mozarc Medical US LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Silex Medical, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
High riskUsing this product could cause serious injury, illness or death — stop using it now.SunMed Holdings, LLC
FDA (openFDA device enforcement)
Reported Jun 11, 2025
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Virtual Incision Corporation
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Apo B Reagent, REF: OSR6143
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Beckman Coulter Ireland, Inc.
FDA (openFDA device enforcement)
Reported Jun 4, 2025
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.C-Rad Positioning Ab
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.