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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Jul 3, 2024
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aspen Surgical
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jul 3, 2024
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Centers For Disease Control and Prevention
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dental EZ Group Star Dental Division
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Inspire Model 3028, IV Implantable Pulse Generator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Inspire Medical Systems Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mermaid Medical A/S
FDA (openFDA device enforcement)
Reported Jul 3, 2024
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NovaSignal Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Inc.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sight Diagnostics Ltd.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
FDA (openFDA device enforcement)
Reported Jul 3, 2024
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec Switzerland GmbH
FDA (openFDA device enforcement)
Reported Jun 26, 2024
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Jun 26, 2024
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaver Visitec International, Inc.
1 more product 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.