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 Oct 9, 2024
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic MiniMed, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Mercury Enterprises, Inc. dba Mercury Medical
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Outset Medical, Inc.
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
High riskUsing this product could cause serious injury, illness or death — stop using it now.Percussionaire Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Oct 9, 2024
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Oct 9, 2024
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 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 Oct 9, 2024
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Oct 9, 2024
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Young Dental Manufacturing I, LLC
FDA (openFDA device enforcement)
Reported Oct 2, 2024
PACEMAKER PACK, SLCV01J; Medical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
18 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ARROW INTERNATIONAL Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of…
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 Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
30 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
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 Oct 2, 2024
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Biotech, Inc.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr Franz Koehler Chemie GmbH
FDA (openFDA device enforcement)
Reported Oct 2, 2024
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher & Paykel Healthcare, Ltd.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
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.