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
Oct 25, 2013	*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE ...	Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assemb...	Class II	Hospira Inc.
Oct 25, 2013	Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cush...	Scales adhered to the product may be misaligned from the zero reference such that one side will n...	Class II	Civco Medical Instruments Inc
Oct 25, 2013	Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion...	Scales adhered to the product may be misaligned from the zero reference such that one side will n...	Class II	Civco Medical Instruments Inc
Oct 25, 2013	VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs	Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P...	Class II	Ortho-Clinical Diagnostics
Oct 24, 2013	Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular comp...	Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop f...	Class II	Ossur North America Inc
Oct 24, 2013	Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD L...	Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer...	Class II	Kimberly-Clark Corporation
Oct 24, 2013	C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelera...	This correction is to notify users that a solution to a previous correction has been developed an...	Class II	Varian Medical Systems, Inc.
Oct 24, 2013	Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, an...	The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when u...	Class II	Nobel Biocare Usa Llc
Oct 23, 2013	BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp...	It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the ti...	Class II	Philips Medical Systems, Inc.
Oct 23, 2013	Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette,...	Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-99...	Class III	Alere San Diego, Inc.
Oct 23, 2013	ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaf...	The affected lots were exposed to a higher than acceptable level of particulate matter during man...	Class II	ConMed Corporation
Oct 23, 2013	Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term car...	It was reported that the siderail may appear latched when it is not, due to lack of proper preven...	Class II	Stryker Medical Division of Stryker Corporation
Oct 23, 2013	ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaf...	The affected lots were exposed to a higher than acceptable level of particulate matter during man...	Class II	ConMed Corporation
Oct 23, 2013	SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: a...	A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Ac...	Class II	Siemens Medical Solutions USA, Inc
Oct 23, 2013	Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-rei...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. ...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, ...	The user database delivered for download contained an erroneous value. Specifically the "aO" cons...	Class II	Carl Zeiss Meditec, Inc.
Oct 23, 2013	Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gel...	Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, ...	The user database delivered for download contained an erroneous value. Specifically the "aO" cons...	Class II	Carl Zeiss Meditec, Inc.
Oct 23, 2013	SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any ph...	A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Ac...	Class II	Siemens Medical Solutions USA, Inc
Oct 23, 2013	Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3...	Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in R...	Class II	RAYSEARCH LABORATORIES AB
Oct 23, 2013	Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 21, 2013	Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS19...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.	Class I	Medtronic Vascular
Oct 21, 2013	Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.	Class I	Medtronic Vascular
Oct 21, 2013	THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, T...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.	Class I	Medtronic Vascular
Oct 21, 2013	Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethyl...	A Hand Piece high deployment force exceeded the maximum specification.	Class II	Urologix, Inc.
Oct 21, 2013	Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue ...	Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During s...	Class II	Applied Medical Resources Corp
Oct 21, 2013	ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.	Class I	Medtronic Vascular
Oct 21, 2013	ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZR...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.	Class I	Medtronic Vascular
Oct 21, 2013	ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PR...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Med...	Class I	Medtronic Vascular
Oct 21, 2013	da Vinci Vision System Cart, a component of the da Vinci Si Surgical System ...	Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompati...	Class III	Intuitive Surgical, Inc.
Oct 21, 2013	COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT19...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.	Class I	Medtronic Vascular
Oct 21, 2013	VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3...	Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a...	Class II	Vital Images, Inc.
Oct 21, 2013	THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are...	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.	Class I	Medtronic Vascular
Oct 18, 2013	Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Cat...	Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) C...	Class II	Stryker Sustainability Solutions
Oct 18, 2013	PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw im...	During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8...	Class II	SpineFrontier, Inc.
Oct 18, 2013	CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"	Product has the potential to have a clear debris on the tip of the needle.	Class II	Intra Pump Infusion Systems
Oct 18, 2013	AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mob...	The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or ma...	Class II	Steris Corporation
Oct 18, 2013	Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture se...	Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare w...	Class II	Advanced Sterilization Products
Oct 17, 2013	CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation,...	Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 a...	Class I	Del Mar Reynolds Medical, Ltd.
Oct 17, 2013	Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. ...	Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because t...	Class II	Spacelabs Healthcare, Llc
Oct 17, 2013	Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief,...	Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.	Class II	GlaxoSmithKline, LLC.
Oct 17, 2013	Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a pati...	Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incor...	Class II	Spacelabs Healthcare, Llc
Oct 17, 2013	Trabecular Metal" Reverse Shoulder System	As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zi...	Class II	Zimmer, Inc.
Oct 17, 2013	VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Di...	Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K...	Class II	Ortho-Clinical Diagnostics
Oct 17, 2013	EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagn...	A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and...	Class II	Philips Medical Systems North America Inc.
Oct 17, 2013	VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnost...	Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K...	Class II	Ortho-Clinical Diagnostics
Oct 17, 2013	15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubin...	The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully c...	Class II	Baxter Healthcare Corp
Oct 16, 2013	The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeCho...	The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that...	Class II	Baxter Healthcare Corp.

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.