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
Oct 29, 2015	NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodia...	Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c...	Class II	NxStage Medical, Inc.
Oct 29, 2015	NxStage System One S Cycler -High Permeability Hemodialysis System Model no...	Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may co...	Class II	NxStage Medical, Inc.
Oct 29, 2015	Ingenuity Core 128 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 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	Ingenuity CT 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 (High Permeability Hemodialysis System) Model no...	Ultrafiltration (UF) Volume software error inaccurate fluid removal	Class II	NxStage Medical, Inc.
Oct 28, 2015	DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to mea...	Device is not functioning as intended: Two wires running to the ECG distribution circuit board a...	Class III	BC Group International Inc
Oct 28, 2015	Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat e...	The products have been found to intermittently exhibit a seal failure during use.	Class II	Quest Medical, Inc.
Oct 28, 2015	ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Steril...	Microcatheter may have circumferential defects (cracks) along its shaft.	Class II	Baylis Medical Corp *
Oct 28, 2015	Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Ste...	This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactu...	Class II	Medtronic Perfusion Systems
Oct 28, 2015	rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; ...	These sensors were manufactured with incompatible configurations. This could result in sensors th...	Class II	Masimo Corporation
Oct 28, 2015	Syngo Imaging VB36D_HF02. Radiological image processing system.	To provide supplementary information regarding the release of the syngo Imaging Software Version ...	Class II	Siemens Medical Solutions USA, Inc
Oct 28, 2015	DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. ...	Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender ...	Class II	Implant Direct Sybron Manufacturing, LLC
Oct 27, 2015	IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ...	IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain t...	Class II	Carl Zeiss Meditec AG
Oct 27, 2015	Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS...	It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - ...	Class III	Lab Vision Corporation
Oct 27, 2015	IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 ...	IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain t...	Class II	Carl Zeiss Meditec AG
Oct 27, 2015	U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles wer...	The firm had received a complaint alleging that a medical professional had difficulty inserting a...	Class II	Procedure Products, Inc.
Oct 26, 2015	PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable impl...	The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl...	Class II	Merz North America, Inc.
Oct 26, 2015	Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated fo...	The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl...	Class II	Merz North America, Inc.
Oct 26, 2015	MiniArc Pro Single incision Sling System, Model number / Product Reference 90...	The lot number on the outer carton label did not match the lot number printed on the tray label o...	Class II	Astora
Oct 26, 2015	Merge Cardio with software version 10.1 LA.	The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer...	Class II	Merge Healthcare, Inc.
Oct 26, 2015	Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation ...	There is cracking in the tray when the device is snapped into place. The crack is through the ful...	Class II	ArthroCare Corporation
Oct 26, 2015	Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named Hear...	The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer...	Class II	Merge Healthcare, Inc.
Oct 26, 2015	PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) I...	The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl...	Class II	Merz North America, Inc.
Oct 23, 2015	GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte...	GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo...	Class II	GE Medical Systems, LLC
Oct 23, 2015	Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use i...	Dissolution units and replacement motors units do not provide full thermal protection for both th...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Oct 23, 2015	Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 A...	Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter hav...	Class II	Medtronic Vascular, Inc.
Oct 23, 2015	Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075...	Dissolution units and replacement motors units do not provide full thermal protection for both th...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Oct 23, 2015	Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the...	Dissolution units and replacement motors units do not provide full thermal protection for both th...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Oct 23, 2015	iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart...	A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall....	Class II	Otto Bock Healthcare GmbH
Oct 22, 2015	Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Te...	Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit a...	Class II	Mercury Enterprises, Inc. dba Mercury Medical
Oct 22, 2015	CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans	Monitor may shut down unintentionally without restarting.	Class II	Innokas Medical Oy
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used...	The wire pass hole is not present on the tools.	Class II	Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight c...	Cook Medical has received six product complaints associated with reports of the 2.6FR curved cath...	Class II	Cook Inc.
Oct 21, 2015	LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STE...	Sterility of the product cannot be assured.	Class II	Civco Medical Instruments Co. Inc.
Oct 21, 2015	CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Pl...	Sterility of the product cannot be assured.	Class II	Civco Medical Instruments Co. Inc.
Oct 21, 2015	CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Gu...	Sterility of the product cannot be assured.	Class II	Civco Medical Instruments Co. Inc.
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking br...	Sterility of the product cannot be assured.	Class II	Civco Medical Instruments Co. 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.