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.

Clear

Date	Product	Reason	Class	Firm
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product ...	Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1)...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System ...	The operators manual does not fully describe the sequence of expected events that will occur when...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan...	TCVS is taking action to update the Operators Manual with the specific instructions to respond to...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 ...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 26, 2013	Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 26, 2013	Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used ...	The device was not appropriately set to mitigate the risk of implant fracture upon rotation insid...	Class II	Atlas Spine, Inc.
Jul 26, 2013	TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 26, 2013	DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY...	During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an a...	Class II	Carestream Health, Inc.
Jul 26, 2013	Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 26, 2013	HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. S...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 26, 2013	CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. ...	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V A...	Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1)...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovas...	Medical device used in cardiovascular procedures is defective.	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan...	TCVS is taking action to update the Operators Manual with the specific instructions to respond to...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in....	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ...	Class II	ASO, LLC
Jul 25, 2013	ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 25, 2013	Stryker Visum 300 Ceiling-mounted Exam Light.	Potential incomplete final weld on the drop tube flange.	Class II	Stryker Communications
Jul 25, 2013	ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vi...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 25, 2013	KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System...	During an internal investigation, a formulation error that occurred was identified during the man...	Class II	Roche Molecular Systems, Inc.
Jul 25, 2013	HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, He...	HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Mi...	Class II	HemoCue AB
Jul 25, 2013	ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro d...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 25, 2013	ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In v...	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 25, 2013	DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone softw...	An anomaly was detected such that, under certain conditions, a summed dose created by Velocity re...	Class II	Velocity Medical Solutions, LLC
Jul 25, 2013	STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization Sys...	The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (...	Class II	Advanced Sterilization Products
Jul 25, 2013	Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a...	Review of on-system electronic product labeling and Instructions for comply with applicable Use i...	Class II	Medtronic Navigation, Inc.
Jul 24, 2013	ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operatin...	An odor and smoke developed - The cause was determined to be a power supply unit sitting in the c...	Class III	Trumpf Medical Systems
Jul 24, 2013	GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St...	On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated...	Class II	Gyrus Medical, Inc
Jul 24, 2013	3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System ...	OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #913...	Class II	OrthoPediatrics Corp
Jul 24, 2013	Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 083104...	Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they...	Class II	Nestle HealthCare Nutrition
Jul 23, 2013	DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L...	Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un...	Class II	Microgenics Corp
Jul 23, 2013	Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories ...	Potential for clinical errors.	Class II	Elekta, Inc.
Jul 22, 2013	Contra-Angle Torque Driver Kit For Certain and External Connection Product...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5....	All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of break...	Class II	Synthes USA HQ, Inc.
Jul 22, 2013	Navigator Surgical Kit Product Usage: Molded plastic tray used in holding...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-...	A pinch point at the end of the table top can cause injury.	Class II	Philips Medical Systems (Cleveland) Inc
Jul 22, 2013	Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Prod...	The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was...	Class II	MCKESSON TECHNOLOGIES INC
Jul 19, 2013	ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access a...	Potential carryover issue that can can cause shortened APTT clotting times on the instrument.	Class II	Instrumentation Laboratory Co.
Jul 19, 2013	ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access a...	Potential carryover issue that can can cause shortened APTT clotting times on the instrument.	Class II	Instrumentation Laboratory Co.
Jul 19, 2013	C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tiss...	Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac...	Class II	Atrium Medical Corporation
Jul 19, 2013	ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully au...	Potential carryover issue that can can cause shortened APTT clotting times on the instrument.	Class II	Instrumentation Laboratory Co.
Jul 19, 2013	ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access a...	Potential carryover issue that can can cause shortened APTT clotting times on the instrument.	Class II	Instrumentation Laboratory Co.
Jul 19, 2013	ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analy...	Potential carryover issue that can can cause shortened APTT clotting times on the instrument.	Class II	Instrumentation Laboratory Co.
Jul 19, 2013	Pipeline Embolization Device (PED) The Pipeline Embolization Device is ind...	Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (...	Class II	Micro Therapeutics Inc, Dba Ev3 Neurovascular
Jul 19, 2013	C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficienc...	Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac...	Class II	Atrium Medical Corporation
Jul 19, 2013	C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue...	Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac...	Class II	Atrium Medical Corporation
Jul 19, 2013	Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile...	Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system durin...	Class II	Blue Belt Technologies MN
Jul 19, 2013	ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analy...	Potential carryover issue that can can cause shortened APTT clotting times on the instrument.	Class II	Instrumentation Laboratory Co.

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.