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 Mar 20, 2024
EasyPoint Needle, 25G x 5/8", REF: 82091
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Retractable Technologies, Inc.
FDA (openFDA device enforcement)
Reported Mar 20, 2024
Shimadzu, Trinias, Digital Angiography System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
FDA (openFDA device enforcement)
Reported Mar 20, 2024
Atellica IM Erythropoietin (EPO) Assay (100 Test)
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 Mar 20, 2024
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Mar 13, 2024
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConvaTec, Inc.
FDA (openFDA device enforcement)
Reported Mar 13, 2024
Synapse PACS - Version 7.1.000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
X3 TRIATHLON CS INSERT NO 3 10 MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
7 more products in this recall
FDA (openFDA device enforcement)
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)
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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.