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 May 13, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centinel Spine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Incorporated
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
One Step 10A in vitro diagnostic test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DFI Co., Ltd.
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Erbe Medical, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
High riskUsing this product could cause serious injury, illness or death — stop using it now.Intuitive Surgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Katalyst Surgical, LLC
11 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medical Action Industries, Inc. 306
FDA (openFDA device enforcement)
Reported May 13, 2026
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
41 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mint Medical GmbH
FDA (openFDA device enforcement)
Reported May 13, 2026
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthorebirth Co. Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2026
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported May 13, 2026
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Inc.
FDA (openFDA device enforcement)
Reported May 13, 2026
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ventec Life Systems, Inc.
FDA (openFDA device enforcement)
Reported May 6, 2026
i-STAT EG7+ cartridge; List Number: 03P76-25;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Point Of Care Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 6, 2026
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Bionics, LLC
FDA (openFDA device enforcement)
Reported May 6, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 6, 2026
iLet Bionic Pancreas, REF: BB1001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beta Bionics, Inc.
FDA (openFDA device enforcement)
Reported May 6, 2026
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 6, 2026
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Clinical Innovations, LLC
FDA (openFDA device enforcement)
Reported May 6, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Depuy (ireland)
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 6, 2026
Brand Name: Leksell Vantage Arc System REF: 1053958
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elekta, Inc.
FDA (openFDA device enforcement)
Reported May 6, 2026
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healthmark Industries Co., Inc.
FDA (openFDA device enforcement)
Reported May 6, 2026
Heraeus, PALAMIX uno. Material Number: 66057893.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Heraeus Medical GmbH (Dental Division)
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 6, 2026
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, 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.