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 Aug 12, 2026
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Happiest Baby, Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hardy Diagnostics
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Innovasis, Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integrated Medcraft LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Critical Care AB
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Merge PACS, medical imaging diagnostic workstation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Munevo GmbH
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nuclein LLC
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oxos Medical Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pride Mobility Products Corp.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Siemens Healthcare Diagnostics, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Therabody, Inc.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Theranica Bioelectronics Ltd.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tissium Sa
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.United Orthopedic Corp.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Moderate riskThis product could cause temporary or reversible health problems — stop using it.IsoTis OrthoBiologics, Inc.
FDA (openFDA device enforcement)
Reported Aug 5, 2026
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medical Action Industries, Inc. 306
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.