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 Sep 14, 2022
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OrthoPediatrics Corp.
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Saranas, Inc.
FDA (openFDA device enforcement)
Reported Sep 14, 2022
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Healthcare
FDA (openFDA device enforcement)
Reported Sep 7, 2022
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
FDA (openFDA device enforcement)
Reported Sep 7, 2022
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
FDA (openFDA device enforcement)
Reported Sep 7, 2022
AggreGuide A-100 Instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aggredyne, Inc.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 7, 2022
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corin Ltd.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Xomed, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 7, 2022
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.New Standard Device Inc.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oculus Optikgeraete GmbH
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 7, 2022
T-SPOT.TB REF TB.300 US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oxford Immunotec Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 7, 2022
DigitalDiagnost C50 1.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Sep 7, 2022
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 7, 2022
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
EVIS EXERA III Bronchovideoscope
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aizu Olympus Co., Ltd.
FDA (openFDA device enforcement)
Reported Aug 31, 2022
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
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.