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 Mar 13, 2024
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Invacare Corporation
FDA (openFDA device enforcement)
Reported Mar 13, 2024
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro Therapeutics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
Phantom TTC Nail, 10.0 X 200mm, Right
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragon 28, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
Embrace Drill Tower, Wedged (25mm)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Molecular, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Acumed LLC
FDA (openFDA device enforcement)
Reported Mar 6, 2024
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.EMD Millipore Corporation
FDA (openFDA device enforcement)
Reported Mar 6, 2024
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Graphenano Dental Sl
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medagent Inc.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
48 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NxStage MDS Corporation
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Colonoscope, Model Number CF-H180AL.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
9 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Parker Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.United Orthopedic Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ventec Life Systems, Inc.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zyno Medical LLC
FDA (openFDA device enforcement)
Reported Feb 28, 2024
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
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.