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.

Date	Product	Reason	Class	Firm
Dec 30, 2014	RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 103223...	Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ...	Class II	Siemens Healthcare Diagnostics Inc
Dec 30, 2014	RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179....	Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ...	Class II	Siemens Healthcare Diagnostics Inc
Dec 30, 2014	RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524....	Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ...	Class II	Siemens Healthcare Diagnostics Inc
Dec 30, 2014	Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx On...	Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.	Class II	Clinical Innovations, LLC
Dec 30, 2014	RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 106968...	Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ...	Class II	Siemens Healthcare Diagnostics Inc
Dec 29, 2014	Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distribu...	Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Tabl...	Class II	Dick's Sporting Goods
Dec 29, 2014	Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Cap...	Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both sin...	Class II	Baxter Corporation Englewood
Dec 29, 2014	VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the fo...	In combination with the Batch Programming option (only) for programming samples, the hand-held ba...	Class II	Ortho-Clinical Diagnostics
Dec 24, 2014	Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425	Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicato...	Class II	Advanced Sterilization Products
Dec 23, 2014	FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limite...	Product distributed without 510(k) approval	Class II	Therasage, LLC.
Dec 23, 2014	Portable FAR Infrared Sauna Indications including, but not limited to Natura...	Product distributed without 510(k) approval	Class II	Therasage, LLC.
Dec 23, 2014	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube t...	A small piece of the stylet sheath has the potential to shear off upon removal of the stylet fro...	Class II	Cardinal Health
Dec 23, 2014	Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). ...	This recall has been initiated because use of the impacted DPIs could result in erroneous testing...	Class II	Shape Medical Systems, Inc
Dec 23, 2014	HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, ...	MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to b...	Class II	Philips Medical Systems, Inc.
Dec 23, 2014	FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limite...	Product distributed without 510(k) approval	Class II	Therasage, LLC.
Dec 22, 2014	SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA ...	The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new f...	Class II	Vitrolife Inc
Dec 22, 2014	Flyte Togas are components of the Stryker Flyte System and are intended to be...	A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled...	Class III	Stryker Instruments Div. of Stryker Corporation
Dec 22, 2014	Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. ...	Shaft breaks so that adequate patient specimen sample cannot be obtained.	Class II	Puritan Medical Products Co., LLC
Dec 22, 2014	Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses i...	One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was ...	Class II	Cordis Corporation
Dec 19, 2014	LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR ...	A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent prot...	Class II	Siemens Medical Solutions USA, Inc
Dec 19, 2014	Monaco radiation therapy treatment planning system. The Monaco system i...	Incorrect CT to ED when using the Monaco Image Statistics Tool.	Class II	Elekta, Inc.
Dec 19, 2014	The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. ...	Through an investigation of complaints, Integra found that there is the possibility for the locki...	Class II	Integra LifeSciences Corporation
Dec 19, 2014	Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for ...	Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.	Class II	BD Biosciences, Systems & Reagents
Dec 19, 2014	Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL100...	Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope	Class II	Fresenius Medical Care Holdings, Inc.
Dec 19, 2014	CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: ...	One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and ...	Class II	BD Biosciences, Systems & Reagents
Dec 19, 2014	Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.	There is the potential for the height adjustable handle to dislodge due to failing locking mechan...	Class II	Sunrise Medical (US) LLC
Dec 19, 2014	Focal Sim radiation therapy treatment planning system	Incorrect CT to ED when using the Monaco Image Statistics Tool.	Class II	Elekta, Inc.
Dec 19, 2014	GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.	Potential safety issue due to a required torque check on three bolted joints of the Revolution CT...	Class II	GE Healthcare
Dec 19, 2014	Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Prod...	Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle ...	Class II	Angiodynamics
Dec 19, 2014	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx	An issue was identified with the mAs accuracy check performed on the system that could result in ...	Class II	GE Healthcare
Dec 19, 2014	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx	An issue was identified with the mAs accuracy check performed on the system that could result in ...	Class II	GE Healthcare
Dec 19, 2014	HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 US...	The lot failed pH specification.	Class II	Fresenius Kabi USA, LLC
Dec 19, 2014	Quickie Q7 Adult Rigid Wheelchair Model EIR4.	There is the potential for the height adjustable handle to dislodge due to failing locking mechan...	Class II	Sunrise Medical (US) LLC
Dec 19, 2014	Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are i...	Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification	Class II	Philips Medical Systems, Inc.
Dec 19, 2014	McKesson Cardiology ECG Management It is a software application designed t...	An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG ...	Class II	McKesson Israel Ltd.
Dec 19, 2014	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx	An issue was identified with the mAs accuracy check performed on the system that could result in ...	Class II	GE Healthcare
Dec 19, 2014	lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164	A crack may develop in the handle to the Inline Persuader, which may progress if the user continu...	Class II	SpineFrontier, Inc.
Dec 19, 2014	Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is in...	In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric...	Class II	Synthes, Inc.
Dec 19, 2014	BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Inj...	The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.	Class II	Becton Dickinson & Company
Dec 18, 2014	cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Inten...	cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS C...	Class III	Roche Molecular Systems, Inc.
Dec 18, 2014	Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software ver...	Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jud...	Class II	St Jude Medical Cardiac Rhythm Management Division
Dec 18, 2014	Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophtha...	The devices were not shipped with the Starter Kits.	Class II	Ziemer Usa Inc
Dec 18, 2014	Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This de...	Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (a...	Class II	Spinal Elements, Inc
Dec 18, 2014	Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer	Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positi...	Class II	Roche Diagnostics Operations, Inc.
Dec 18, 2014	The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automat...	There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.	Class II	Sysmex Corporation
Dec 17, 2014	MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) R...	Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Ti...	Class II	Stryker Craniomaxillofacial Division
Dec 17, 2014	Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Hep...	The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit L...	Class III	Smiths Medical ASD, Inc.
Dec 17, 2014	Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Hea...	Control units were equipped with an internal mounting kit that does not meet medical safety stand...	Class II	Pivotal Health Solutions
Dec 17, 2014	MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot...	Potential for implant damage, implant cracking off/breaking intra-operatively.	Class II	Stryker Craniomaxillofacial Division
Dec 17, 2014	Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in ...	Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur...	Class II	Zimmer Gmbh

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.