Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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Date	Product	Reason	Class	Firm
Nov 3, 2015	Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.	Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the el...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifie...	Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage...	Class II	Ortho-Clinical Diagnostics
Nov 3, 2015	INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 s...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine sta...	Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors a...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 3, 2015	INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 syste...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie...	Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage...	Class II	Ortho-Clinical Diagnostics
Nov 3, 2015	MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the...	A component of the kit was found to contain bacterial contamination.	Class III	Diagnostic Hybrids, Inc.
Nov 3, 2015	INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 30...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ...	MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p...	Class II	bioMerieux, Inc.
Nov 3, 2015	MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer appl...	MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p...	Class II	bioMerieux, Inc.
Nov 3, 2015	Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicia...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, ...	Leads may have been compromised during the manufacturing process, with cuts in the insulation lay...	Class I	St Jude Medical Cardiac Rhythm Management Division
Nov 3, 2015	NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No....	Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int...	Class II	AngioDynamics Inc.
Nov 3, 2015	INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 syst...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer appl...	MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p...	Class II	bioMerieux, Inc.
Nov 3, 2015	NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601...	Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int...	Class II	AngioDynamics Inc.
Nov 3, 2015	NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 6...	Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int...	Class II	AngioDynamics Inc.
Nov 3, 2015	INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 syst...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 syst...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer applicati...	MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p...	Class II	bioMerieux, Inc.
Nov 3, 2015	Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated va...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 syste...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif...	Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage...	Class II	Ortho-Clinical Diagnostics
Nov 3, 2015	Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardi...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular an...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovas...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system ...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Card...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 300...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ...	MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p...	Class II	bioMerieux, Inc.
Nov 3, 2015	Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 72...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 2, 2015	ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 580...	There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that th...	Class II	Leonhard Lang Medizintechnik GmbH
Nov 2, 2015	AMS 4674 Custom Pack. For use in a general clinical procedure.	AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinge...	Class II	Windstone Medical Packaging, Inc.
Nov 2, 2015	Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/R...	TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent ...	Class II	Synthes (USA) Products LLC
Nov 2, 2015	AMS 4675 Angio Pack. For use in a general clinical procedure.	AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger...	Class II	Windstone Medical Packaging, Inc.
Nov 2, 2015	OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Produc...	Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechan...	Class I	Insulet Corporation
Nov 2, 2015	OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product ...	Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechan...	Class I	Insulet Corporation
Nov 2, 2015	Irrigation Clip 30; Intended to position and hold irrigation tubing during su...	Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).	Class II	The Anspach Effort, Inc.
Nov 2, 2015	Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted ...	The firm has received 15 complaints over ten years related to the connection of the spring arm to...	Class II	Trumpf Medical Systems, Inc.
Nov 2, 2015	2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixat...	It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the inco...	Class II	Synthes (USA) Products LLC
Oct 30, 2015	RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx ...	An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner ...	Class II	BioHorizons Implant Systems Inc
Oct 30, 2015	Artis systems with large display from Siemens Medical Solutions USA, Inc. In...	Due to improper soldering in a limited number of large display bypass module components of a spec...	Class II	Siemens Medical Solutions USA, Inc
Oct 30, 2015	BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5...	Three lots of CD64 (MD22) are contaminated with CD4 antibody.	Class II	Becton, Dickinson and Company, BD Biosciences
Oct 29, 2015	Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device Th...	A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolv...	Class II	Zimmer Biomet, Inc.
Oct 29, 2015	NxStage System One S Cycler (High Permeability Hemodialysis System) Model no...	Ultrafiltration (UF) Volume software error inaccurate fluid removal	Class II	NxStage Medical, Inc.
Oct 29, 2015	Brilliance 64 Computed Tomography X-ray system	Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a...	Class II	Philips Medical Systems (Cleveland) Inc
Oct 29, 2015	Brilliance iCT SP Computed Tomography X-ray system	Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a...	Class II	Philips Medical Systems (Cleveland) Inc
Oct 29, 2015	NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.	Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c...	Class II	NxStage Medical, Inc.
Oct 29, 2015	Ingenuity Core Computed Tomography X-ray system	Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a...	Class II	Philips Medical Systems (Cleveland) 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.