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 10, 2015	MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The Med...	A small number of specific pumps may trigger a low battery alarm at the beginning of the implante...	Class II	Codman & Shurtleff, Inc.
Nov 10, 2015	Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trig...	The firm identified a malfunction which made it possible for a handpiece to start by itself when ...	Class II	Zimmer, Inc.
Nov 10, 2015	Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG:...	The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris...	Class II	Aesculap, Inc.
Nov 10, 2015	MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The Med...	A small number of specific pumps may trigger a low battery alarm at the beginning of the implante...	Class II	Codman & Shurtleff, Inc.
Nov 10, 2015	Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: ...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics Inc.
Nov 10, 2015	Tray Set containing multiple instruments and may contain the flexible bone aw...	The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris...	Class II	Aesculap, Inc.
Nov 10, 2015	UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5...	Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured in...	Class II	OrthoPediatrics Corp
Nov 10, 2015	Reagent Management System (RMS) Dimension EXL with LM STM Product Usage:...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics Inc.
Nov 10, 2015	Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG ...	The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris...	Class II	Aesculap, Inc.
Nov 10, 2015	Philips Healthcare DuraDiagnost stationary X-ray system	The detector may signal that it is ready for acquisition when it actually is not, resulting in f...	Class II	Philips Healthcare
Nov 10, 2015	Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trig...	The firm identified a malfunction which made it possible for a handpiece to start by itself when ...	Class II	Zimmer, Inc.
Nov 10, 2015	Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aescul...	The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris...	Class II	Aesculap, Inc.
Nov 10, 2015	Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling...	Improper targeted temperature therapy was delivered to patients because the Temperature Simulator...	Class II	C.R. Bard, Inc.
Nov 10, 2015	Philips Healthcare DigitalDiagnost stationary X-ray system	The detector may signal that it is ready for acquisition when it actually is not, resulting in f...	Class II	Philips Healthcare
Nov 10, 2015	Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a m...	The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image...	Class II	Shimadzu Medical Systems
Nov 9, 2015	Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The pr...	The product may contain electronic components that lead to a premature drainage of the internal c...	Class II	C.R. Bard, Inc.
Nov 9, 2015	Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat...	Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte...	Class II	Medtronic Inc.
Nov 9, 2015	Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUN...	One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced...	Class II	Smith & Nephew, Inc.
Nov 8, 2015	Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100...	Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuou...	Class II	Vidco, Inc.
Nov 6, 2015	MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; T...	Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE ...	Class II	Cardica, Inc.
Nov 6, 2015	MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30...	Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE ...	Class II	Cardica, Inc.
Nov 6, 2015	Destination Renal Guiding Sheath Intended for the introduction of interven...	Based on internal investigation and testing that revealed the distal end of certain lots of Terum...	Class II	Terumo Medical Corporation
Nov 6, 2015	Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT002...	Antibiotic concentration may be insufficient which may result in incorrect test results.	Class II	Remel Inc
Nov 6, 2015	Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable ...	Particulates: Complaints of rubber coring from the closure of injection vials.	Class II	Myco Medical Supplies Inc
Nov 5, 2015	Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 ...	Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiec...	Class II	ConMed Corporation
Nov 5, 2015	Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior C...	Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft...	Class II	Genesys Orthopedics Systems, LLC
Nov 5, 2015	RT Elements are applications for radiation treatment planning for use in ster...	Large objects with fine resolution are potentially displayed cropped when imported into Brainlab ...	Class II	Brainlab AG
Nov 5, 2015	Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administe...	CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection a...	Class II	CareFusion 303, Inc.
Nov 5, 2015	RT Elements are applications for radiation treatment planning for use in ster...	Large objects with fine resolution are potentially displayed cropped when imported into Adaptive ...	Class II	Brainlab AG
Nov 4, 2015	Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part N...	Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation...	Class II	Ormco/Sybronendo
Nov 4, 2015	Thin-Flex Venous Cannula, Model Number:TF292902A	Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) ...	Class II	Edwards Lifesciences, LLC
Nov 3, 2015	MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection o...	A component of the kit was found to contain bacterial contamination.	Class III	Diagnostic Hybrids, Inc.
Nov 3, 2015	UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use...	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; Model Number: 722038 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	Allura Xper FD20/15; Model Numbers: 722058 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	Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular...	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 BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000...	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 FD OR Table, Ceiling version only; 722035; 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	INTEGRIS V5000: Model Number: 72248 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	INTEGRIS HM3000; Model Number: 72239 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	Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular a...	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	Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is in...	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 Biplane OR Table; Model Numbers: 722025 722020 Dedicated ...	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	NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 6523002...	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 Allura 9 (biplane); Model Number: 722021 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	VITROS 5600 Chemistry System, Catalog Number 6802413, 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	MYLA MASTER DVD V4.0 CLI 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 MASTER DVD V4.1 CLI 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	MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. ...	A component of the kit was found to contain bacterial contamination.	Class III	Diagnostic Hybrids, Inc.
Nov 3, 2015	UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on hum...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation

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.