Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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Date	Product	Reason	Class	Firm
Sep 16, 2013	Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS ...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 13, 2013	pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints ...	Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.	Class II	Mesa Laboratories, Inc.
Sep 13, 2013	NX3 Try-In Gel. The product is used as a tooth shade resin material.	Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-...	Class II	Kerr/Pentron, DBA Kerr Corporation and Pentron ...
Sep 13, 2013	Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparosc...	CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed...	Class II	CooperSurgical, Inc. D.B.A. Lone Star Medical P...
Sep 13, 2013	Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. T...	Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly l...	Class II	Southern Implants, Inc
Sep 13, 2013	Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560...	4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.	Class II	Merit Medical Systems, Inc.
Sep 12, 2013	Solea 1.0 Laser Surgical instrument for use in general and plastic surgery an...	Specific error condition could lead to unintended laser emission during laser activation.	Class II	Convergent Dental
Sep 12, 2013	MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf...	It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device ma...	Class II	Maquet Medical Systems USA
Sep 12, 2013	Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay Sy...	Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fus...	Class II	Beckman Coulter Inc.
Sep 11, 2013	Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscop...	The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which...	Class II	Leica Microsystems, Inc.
Sep 11, 2013	Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. ...	The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which...	Class II	Leica Microsystems, Inc.
Sep 11, 2013	The Rotoprone therapy System is an advanced patient care system for the treat...	The lock pin can become stuck in the "in" position during the manual rotation, resulting in the i...	Class II	ArjoHuntleigh Inc.
Sep 11, 2013	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-...	FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket...	Class II	SonoSite, Inc.
Sep 11, 2013	Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Ha...	Potential for leur connector to leak or have cracks.	Class II	Harvest Technologies Corporation
Sep 11, 2013	PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.	Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect sp...	Class II	SpineFrontier, Inc.
Sep 11, 2013	*REF 186-01-08InteGrip ACETABULAR AUGMENT**SMALL 8mm. Use with 48/50mm ...	Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in...	Class II	Exactech, Inc.
Sep 11, 2013	The Artis zee / zeego Angiography System is designed as a set of components t...	There is a potential issue on running Artis systems running software VC1x software if a network p...	Class II	Siemens Medical Solutions USA, Inc
Sep 10, 2013	Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, A...	Hospira has become aware of customers using the incorrect size Receptal liners with their Recepta...	Class II	Hospira Inc.
Sep 10, 2013	VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STER...	STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM ...	Class II	Steris Corporation
Sep 10, 2013	Dual Luer Lock Cap The device is intended for use as a cap for male or fem...	The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging...	Class II	Baxter Healthcare Corp.
Sep 10, 2013	Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Ve...	Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V...	Class II	Smiths Medical ASD, Inc.
Sep 10, 2013	Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away S...	Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V...	Class II	Smiths Medical ASD, Inc.
Sep 10, 2013	Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, pack...	Expired active ingredient was used in the manufacture of the product.	Class II	Wexford Labs Inc
Sep 10, 2013	Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Ca...	Integra LifeSciences has identified through an internal evaluation that in order to comply with U...	Class II	Integra Limited
Sep 10, 2013	Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Nu...	Hospira has become aware of customers using the incorrect size Receptal liners with their Recepta...	Class II	Hospira Inc.
Sep 10, 2013	Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar ...	Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did...	Class II	Aesculap, Inc.
Sep 9, 2013	*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBL...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemi...	The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry An...	Class II	Beckman Coulter Inc.
Sep 9, 2013	*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BL...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH ...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Ana...	The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry An...	Class II	Beckman Coulter Inc.
Sep 9, 2013	*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE P...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, package...	An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on as...	Class II	Becton Dickinson & Co.
Sep 6, 2013	DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms...	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ...	Class II	Winco Mfg., LLC
Sep 6, 2013	Selenia Full Field Digital Mammography System with software versions 5.0.x an...	Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the ...	Class II	Hologic, Inc.
Sep 6, 2013	Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rH...	The recall was initiated due to an increased risk of implants breaching the sterile pouches insid...	Class II	Small Bone Innovations, Inc.
Sep 6, 2013	chromID Salmonella Agar, Reference No. 43621. A selective isolation and di...	Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colo...	Class II	bioMerieux, Inc.
Sep 6, 2013	ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essentia...	HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting ...	Class III	Horiba Instruments, Inc dba Horiba Medical
Sep 6, 2013	CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholste...	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ...	Class II	Winco Mfg., LLC
Sep 6, 2013	XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold...	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ...	Class II	Winco Mfg., LLC
Sep 6, 2013	PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table option...	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ...	Class II	Winco Mfg., LLC
Sep 5, 2013	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 0619890...	Some devices may be contaminated on the back side of the device with glue in the blood applicatio...	Class II	Perkin Elmer Health Sciences, Inc.
Sep 5, 2013	Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear...	CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher ...	Class I	Carefusion 211 Inc dba Carefusion
Sep 4, 2013	Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INS...	Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integr...	Class II	Integra LifeSciences Corp. d.b.a. Integra Pain ...
Sep 4, 2013	McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, ...	Software malfunction may occur resulting in a certain combination of server configurations which ...	Class II	Mckesson Information Solutions LLC

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.