Browse Device Recalls

209 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 209 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 209 FDA device recalls in 2011.

Date	Product	Reason	Class	Firm
Dec 30, 2011	KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods a...	One of the rods in each of two test constructs did not meet fatigue requirement as outlined in AS...	Class II	SpineFrontier, Inc.
Dec 29, 2011	Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics ...	Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle A...	Class II	Stryker Howmedica Osteonics Corp.
Dec 29, 2011	Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-0...	Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their ...	Class II	Stryker Howmedica Osteonics Corp.
Dec 23, 2011	SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Inte...	It has been verified through field use that there are two possible breakages that may occur when ...	Class II	SpineFrontier, Inc.
Dec 22, 2011	Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. M...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various mo...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufacture...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactur...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whiteni...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Ost...	Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted ...	Class II	Stryker Howmedica Osteonics Corp.
Dec 22, 2011	Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufac...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge ...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in Ch...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made ...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. M...	Church and Dwight plans to take actions to best convey to the public the potential small parts ch...	Class II	Church & Dwight Inc
Dec 22, 2011	Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc...	US Endoscopy received five complaints which noted difficulty in deploying the cytology brush thro...	Class II	US Endoscopy Group Inc
Dec 20, 2011	GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ,...	While performing a fluoroscopic examination on the GE Innova systems, there is a potential of non...	Class II	GE Healthcare, LLC
Dec 20, 2011	GE Healthcare innova 3100, Mobile X-ray system. The innova systems are in...	It was discovered of a potential failure of the spectral filter mechanism inside the collimator o...	Class II	GE Healthcare, LLC
Dec 20, 2011	GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are ...	It was discovered of a potential failure of the spectral filter mechanism inside the collimator o...	Class II	GE Healthcare, LLC
Dec 20, 2011	GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are i...	It was discovered of a potential failure of the spectral filter mechanism inside the collimator o...	Class II	GE Healthcare, LLC
Dec 19, 2011	Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is ...	The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in pla...	Class II	Biomet Spine, LLC
Dec 19, 2011	Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be con...	As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th...	Class II	Advanced Neuromodulation Systems Inc.
Dec 19, 2011	The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rech...	As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th...	Class II	Advanced Neuromodulation Systems Inc.
Dec 19, 2011	Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indica...	The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or...	Class II	Advanced Neuromodulation Systems Inc.
Dec 15, 2011	Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number ...	The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron...	Class III	Beckman Coulter Inc.
Dec 13, 2011	UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Sl...	The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Fl...	Class II	Beckman Coulter Inc.
Dec 13, 2011	UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidem...	The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Fl...	Class II	Beckman Coulter Inc.
Dec 12, 2011	Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.	The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections ...	Class II	Ormco/Sybronendo
Dec 9, 2011	Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), R...	Some of the sterile packages had broken seals.	Class II	Progressive Medical Inc
Dec 8, 2011	PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490...	Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k...	Class II	Tripath Imaging, Inc.
Dec 8, 2011	PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a li...	Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k...	Class II	Tripath Imaging, Inc.
Dec 8, 2011	PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin ...	Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k...	Class II	Tripath Imaging, Inc.
Dec 8, 2011	PrepStain Slide Processor. The PrepStain System is a liquid-based thin lay...	Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k...	Class II	Tripath Imaging, Inc.
Dec 5, 2011	Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry	The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4...	Class II	Sunquest Information Systems, Inc.
Nov 30, 2011	Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS...	The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX...	Class II	Abbott Vascular
Nov 30, 2011	TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to ...	The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) ...	Class II	Toshiba American Medical Systems Inc
Nov 21, 2011	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWIN...	Screen save images are included in wrong exam due to duplicate UID creation. This may cause a saf...	Class II	GE Healthcare, LLC
Nov 17, 2011	Freedom Cordless LED Light System. Freedom System, Standard Length, Part Numb...	The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an in...	Class II	Kerr Corporation
Nov 15, 2011	Sunquest Laboratory : intended for use by professionals working in a clini...	Online calculations may not be performed as expected or may yield results that are different than...	Class III	Sunquest Information Systems, Inc.
Nov 14, 2011	Endoscopic retrieval device. The disposable Raptor grasping device in inte...	When the outer catheter is either coiled or in a contorted configuration outside of the endoscope...	Class II	US Endoscopy Group Inc
Nov 9, 2011	ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening a...	A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST...	Class II	Hyphen BioMed
Nov 9, 2011	ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for ...	A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST...	Class II	Hyphen BioMed
Nov 4, 2011	Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection...	On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certa...	Class II	Biomet 3i, LLC
Nov 3, 2011	Sunquest Laboratory, version 7.0 not available	Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-c...	Class II	Sunquest Information Systems, Inc.
Oct 28, 2011	Fusion Workstation.; Indicated for the transmission and review of radiologica...	After a period of time running Fusion Workstation, the Hounsfield measurement tool will report in...	Class II	Merge Healthcare, Inc.
Oct 28, 2011	R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ...	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x...	Class II	Shimadzu Medical Systems
Oct 28, 2011	0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system i...	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x...	Class II	Shimadzu Medical Systems
Oct 28, 2011	Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), R...	The tip of the product could come loose or unravel.	Class II	Progressive Medical Inc
Oct 28, 2011	R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ...	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x...	Class II	Shimadzu Medical Systems
Oct 28, 2011	0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray sys...	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x...	Class II	Shimadzu Medical Systems

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.