Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,729 FDA device recalls in 2014.

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Date	Product	Reason	Class	Firm
Nov 3, 2014	8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuiti...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Oct 31, 2014	The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bi...	Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenat...	Class II	Medtronic Perfusion Systems
Oct 31, 2014	Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged on...	The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential ...	Class II	Invacare Corporation
Oct 31, 2014	UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary p...	Packaging non-conformance related to the integrity of the sterile pouch seal.	Class II	US Endoscopy Group Inc
Oct 31, 2014	CyberKnife Robotic Radiosurgery System with the first generation IRIS Variabl...	Software upgrade to correct potential safety issue related to CyberKnife System that occurs when ...	Class II	Accuray Incorporated
Oct 30, 2014	ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to ...	Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management a...	Class II	Roche Diabetes Care, Inc.
Oct 30, 2014	INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. S...	Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in t...	Class II	Alcon Research, Ltd.
Oct 30, 2014	CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images th...	Reduced mammographic image quality when attempting to print true size multi-format images	Class II	Carestream Health, Inc.
Oct 29, 2014	Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V...	If the power supply fan mounting screws are installed incorrectly, the ends of the screws may tou...	Class II	Respironics California Inc
Oct 29, 2014	Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL8...	Negative drift on QC during in-use lifetime of CREA membranes can be observed.	Class II	Radiometer America Inc
Oct 29, 2014	10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Ster...	The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assemble...	Class II	Synthes, Inc.
Oct 29, 2014	Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottl...	The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosi...	Class II	Remel Inc
Oct 28, 2014	Mammomat Inspiration system: Product Usage: mammography exams, screening...	It was determined that if the Mammomat Inspiration system is not secured to the floor (per custom...	Class II	Siemens Medical Solutions USA, Inc
Oct 28, 2014	The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position ...	The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the...	Class II	Summit Industries Inc.
Oct 28, 2014	Soft Contact Lens	Portions of the lots may contain units with an incorrect lens axis condition.	Class II	Cooper Vision Caribbean Corp.
Oct 27, 2014	CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft...	Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Ra...	Class II	CooperSurgical, Inc.
Oct 27, 2014	Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switc...	Potential breach of sterile barrier due to defective product tray.	Class II	ArthroCare Medical Corporation
Oct 27, 2014	Drill set long, drill stop compatible for 4.8mm diameter implant, Article Num...	Drill set may contain incorrect drill.	Class II	Straumann USA, LLC
Oct 27, 2014	Turbo Troponin I For in vitro diagnostic use for the quantitative measurem...		Class II	Siemens Healthcare Diagnostics, Inc.
Oct 27, 2014	Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgic...	The product has been identified to contain an incorrect curette type.	Class III	CooperSurgical, Inc.
Oct 24, 2014	Integra Titan Reverse Shoulder System right and left head cutting templates, ...	A single lot of left and a single lot of right Reverse Shoulder System cutting templates were man...	Class II	Integra LifeSciences Corp.
Oct 24, 2014	The Dual Switch Valve is used for fluid drainage from the ventricles into the...	Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to i...	Class II	Aesculap, Inc.
Oct 24, 2014	Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivi...	Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening...	Class II	Discus Dental LLC
Oct 24, 2014	GE Discovery MR950 MRI system	The alignment lasers are missing the labels required by radiation safety regulations.	Class II	GE Healthcare
Oct 24, 2014	Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12...	Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin lin...	Class III	AGFA Healthcare Corp.
Oct 23, 2014	Nerve Block Tray (Nerve Block convenience kit)	According to the recall notice received from Hospira, the recall was initiated due to a confirmed...	Class II	Centurion Medical Products Corporation
Oct 23, 2014	Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)	According to the recall notice received from Hospira, the recall was initiated due to a confirmed...	Class II	Centurion Medical Products Corporation
Oct 23, 2014	Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests ...	A reagent within the test may return false negative results.	Class II	Remel Inc
Oct 23, 2014	Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)	According to the recall notice received from Hospira, the recall was initiated due to a confirmed...	Class II	Centurion Medical Products Corporation
Oct 23, 2014	ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for:...	Some of vials were found to be partially filled.	Class II	TEM Systems Inc
Oct 23, 2014	Abbott m2000sp, an automated system for performing sample preparation for nuc...	Some versions of Application Specifications (App Spec) are incompatible with m2000sp system softw...	Class II	Abbott Molecular
Oct 23, 2014	JResultNet drivers using ASTM coding language. Calculator/data processing mo...	Software issue resulting in the results of one patient potentially being associated with another.	Class II	Data Innovations, LLC
Oct 23, 2014	Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box co...	A reagent within the test may return false negative results.	Class II	Remel Inc
Oct 23, 2014	MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC...	MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values...	Class III	Medtest Holdings, Inc.
Oct 23, 2014	Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: T...	Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws...	Class I	Synthes (USA) Products LLC
Oct 23, 2014	Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determin...	Product is not performing according to specifications. Control 2 does not consistently recover wi...	Class II	JAS Diagnostics Inc.
Oct 23, 2014	Diagnostic Imaging Tray (General Surgery convenience kit)	According to the recall notice received from Hospira, the recall was initiated due to a confirmed...	Class II	Centurion Medical Products Corporation
Oct 22, 2014	Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to e...	Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers...	Class II	Stryker Neurovascular
Oct 22, 2014	Philips Expression MR200 MRI Patient Monitoring System.	The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; po...	Class II	Invivo Corporation
Oct 22, 2014	GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for emboli...	Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers...	Class II	Stryker Neurovascular
Oct 22, 2014	GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for emb...	Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers...	Class II	Stryker Neurovascular
Oct 22, 2014	GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for ...	Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers...	Class II	Stryker Neurovascular
Oct 22, 2014	Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated fo...	Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers...	Class II	Stryker Neurovascular
Oct 21, 2014	HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal...	The keypad buttons on HomeChoice devices may be activated without the operator pressing them.	Class II	Baxter Healthcare Corp.
Oct 21, 2014	Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE...	All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile...	Class II	Gyrus Acmi, Incorporated
Oct 21, 2014	The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert th...	The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and co...	Class II	Medacta Usa
Oct 20, 2014	Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA p...	A gel-like substance was found in kit component, sample diluent , that could potentially compromi...	Class II	Diamedix Corporation
Oct 20, 2014	MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for ...	MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes C...	Class II	Microgenics Corporation
Oct 20, 2014	ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drain...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT ...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.