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 Jul 26, 2023
Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
52 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.UFSK - International OSYS GmbH
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Jul 19, 2023
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Oxylog 3000 Plus emergency and transport ventilator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
FDA (openFDA device enforcement)
Reported Jul 19, 2023
GE Healthcare Vivid S60, ultrasound device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Vingmed Ultrasound As
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported Jul 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
FDA (openFDA device enforcement)
Reported Jul 19, 2023
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Osteomed, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
FDA (openFDA device enforcement)
Reported Jul 12, 2023
BD Synapsys Informatics Solution, Catalog Number 444150
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datex--Ohmeda, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Full Vision Inc.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare Finland Oy
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.NeuMoDx Molecular 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.