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 Mar 6, 2024
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
48 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NxStage MDS Corporation
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Colonoscope, Model Number CF-H180AL.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
9 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Parker Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.United Orthopedic Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ventec Life Systems, Inc.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zyno Medical LLC
FDA (openFDA device enforcement)
Reported Feb 28, 2024
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
FDA (openFDA device enforcement)
Reported Feb 28, 2024
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AMD Medicom Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Baxter Exactamix Pro 1200, REF EXM12DY
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 Feb 28, 2024
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Feb 28, 2024
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Canon Medical System, USA, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
9 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Impulse Dynamics (usa) Inc.
FDA (openFDA device enforcement)
Reported Feb 28, 2024
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Feb 28, 2024
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MRP, LLC dba Aquabiliti
FDA (openFDA device enforcement)
Reported Feb 28, 2024
ESG PK CUTTING FORCEPS, 5MM, 33CM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
7 more products in this recall
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.