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 Aug 10, 2022
Turbett Surgical Container, TS1500
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Turbett Surgical, Inc.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bard Access Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Aug 3, 2022
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Aug 3, 2022
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Davol, Inc.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Centricity PACS Software Version 7.0 SP0.0.4.7
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Aug 3, 2022
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP - Spt
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Revogene, Catalog no. 610210. IVD test instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Meridian Bioscience Inc.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
nordicBrainEX, software versions 2.21 through 2.3.10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NordicNeuroLab AS
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NuVasive Inc.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragon 28, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sight Diagnostics Ltd.
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments
FDA (openFDA device enforcement)
Reported Aug 3, 2022
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Touch US LLC
FDA (openFDA device enforcement)
Reported Aug 3, 2022
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Zeiss, Carl Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ambu Inc.
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
10 more products in this recall
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.