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 11, 2014	AlignRT is a video-based three-dimensional (3D) surface imaging system which ...	Potential use error when the external Gate Controller is turned ON after the Vision RT software...	Class II	Vision Rt Inc
Nov 11, 2014	Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-53...	A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleev...	Class II	Ebi, Llc
Nov 11, 2014	Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: ...	Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS ...	Class II	Siemens Medical Solutions USA, Inc
Nov 11, 2014	ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For us...	Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ...	Class I	Heart Sync, Inc.
Nov 11, 2014	Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC ...	Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric...	Class II	Cure Medical LLC
Nov 10, 2014	Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors a...	ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc...	Class II	DePuy Orthopaedics, Inc.
Nov 10, 2014	MEVION S250, used for proton radiation therapy.	Software defect that causes an incorrect dose compensation function to be applied to the internal...	Class II	Mevion Medical Systems, Inc.
Nov 10, 2014	Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w...	Incorrect lumi firmware version installed (E.027 instead of V2.00)	Class III	Tecan US, Inc.
Nov 10, 2014	The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in ...	Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during i...	Class II	DePuy Orthopaedics, Inc.
Nov 10, 2014	Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Imp...	ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc...	Class II	DePuy Orthopaedics, Inc.
Nov 10, 2014	CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device *...	An increase in complaint trending for a loss of audible sound associated with the timer has been ...	Class II	CSA Medical
Nov 10, 2014	GE Cabinet X-ray systems	GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray Sys...	Class II	GE Inspection Technologies, LP
Nov 10, 2014	Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade...	Incorrect lumi firmware version installed (E.027 instead of V2.00)	Class III	Tecan US, Inc.
Nov 10, 2014	Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of c...	Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-...	Class II	Arrow International Inc
Nov 10, 2014	Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactor...	ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc...	Class II	DePuy Orthopaedics, Inc.
Nov 10, 2014	GE Optional Laser Centering Device X-ray generator.	GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 f...	Class II	GE Inspection Technologies, LP
Nov 10, 2014	CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software...	The firm is informing customers of a software error that might result in an inaccurate display of...	Class III	Medtronic MiniMed Inc.
Nov 9, 2014	IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/...	Software defect. In certain circumstances, the application may display incorrect measurements of...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 7, 2014	Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm,...	Tubing detachment	Class II	Unomedical As
Nov 7, 2014	Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care	Unintended treatment termination could result from a keypad malfunction in some situations. The d...	Class II	Breas Medical AB
Nov 7, 2014	3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm ...	Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis...	Class II	Biomet 3i, LLC
Nov 7, 2014	Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Par...	Tubing detachment	Class II	Unomedical As
Nov 7, 2014	BD Viper LT System, catalog number 442839 when used in conjunction with the B...	Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) re...	Class II	Becton Dickinson & Co.
Nov 7, 2014	SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm...	Tubing detachment	Class II	Unomedical As
Nov 7, 2014	Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxyg...	Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since Oc...	Class II	Integra LifeSciences Corp.
Nov 7, 2014	Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach,...	Tubing detachment	Class II	Unomedical As
Nov 7, 2014	AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/...	Tubing detachment	Class II	Unomedical As
Nov 7, 2014	Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 ...	Tubing detachment	Class II	Unomedical As
Nov 7, 2014	OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.	Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis...	Class II	Biomet 3i, LLC
Nov 7, 2014	adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used wit...	Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Sou...	Class II	Ion Beam Applications S.A.
Nov 7, 2014	OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental ...	Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis...	Class II	Biomet 3i, LLC
Nov 7, 2014	Ceramic Femoral Head. Intended for use in total hip arthroplasty applica...	Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (...	Class II	DePuy Orthopaedics, Inc.
Nov 6, 2014	CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direc...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPA...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro di...	Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.	Class II	Ortho-Clinical Diagnostics
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- CO...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace th...	Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CM...	Class II	Integra LifeSciences Corp.
Nov 6, 2014	PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- C...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- CO...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnost...	Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when u...	Class III	Illumina Inc
Nov 6, 2014	Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electr...	The device may operate solely in reverse mode, not operate in reverse mode when intended, not fun...	Class II	Synthes (USA) Products LLC
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COM...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and P...	Breakage of the nut that secures the heater head in place, which can cause the heater head to bec...	Class II	Fisher & Paykel Healthcare, Ltd.
Nov 6, 2014	CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, D...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY ...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 6, 2014	Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate...	AMO has received complaints where the finger grip dislodged while depressing the syringe plunger....	Class II	Abbott Medical Optics Inc (AMO)
Nov 6, 2014	ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to gu...	Potential failure of a force feedback sensor that may result in continued movement of an operatin...	Class II	Zimmer Biomet, Inc.
Nov 6, 2014	ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPA...	Philips Healthcare made changes to the design of the connection between multifunction electrodes ...	Class I	ConMed Corporation
Nov 5, 2014	Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ...	Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ...	Class II	Toshiba American Medical Systems Inc
Nov 5, 2014	Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps...	When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a...	Class II	Philips Ultrasound, 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.