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 Nov 19, 2025
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Technology Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cerenovus Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medline Industries, LP
20 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Nov 19, 2025
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Miach Orthopaedics
FDA (openFDA device enforcement)
Reported Nov 19, 2025
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuroLogica Corporation
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix U.S. LLC
FDA (openFDA device enforcement)
Reported Nov 19, 2025
ProxiDiagnost N90; Model Number: 706110;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems DMC GmbH
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Respironics, Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
FDA (openFDA device enforcement)
Reported Nov 19, 2025
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sonesta Medical AB
FDA (openFDA device enforcement)
Reported Nov 19, 2025
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Techno-Path Manufacturing Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B-K Medical A/S
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
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.