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 Nov 13, 2024
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corp.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Elekta Instrument AB
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
FDA (openFDA device enforcement)
Reported Nov 13, 2024
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Iotamotion Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nihon Kohden America Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ambu Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
FDA (openFDA device enforcement)
Reported Nov 6, 2024
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex--Ohmeda, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.DRG International, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ImaCor Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.King Systems Corp. dba Ambu, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, 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.