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
Sep 11, 2015	One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.	Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Bu...	Class II	Boston Scientific Corp
Sep 11, 2015	NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne d...	When using the NicoletOne v5.94 software, after exiting the impedance check function and returnin...	Class II	Natus Neurology Inc
Sep 11, 2015	MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a con...	small puncture marks in a sterile package for an accessory to an Olympus device	Class II	Olympus Corporation of the Americas
Sep 11, 2015	Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder ...	Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labe...	Class III	Acumedia Manufacturers, Inc.
Sep 10, 2015	VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D...	Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versio...	Class II	Ortho-Clinical Diagnostics
Sep 10, 2015	MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICr...	Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi...	Class II	Beckman Coulter Inc.
Sep 10, 2015	Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ...	Sterility of device is compromised due to breach in the packaging	Class II	Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015	Carto 3 EP Navigation System. Electro physiology system which views of the el...	Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed...	Class II	Biosense Webster, Inc.
Sep 10, 2015	DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7...	These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drap...	Class II	DeRoyal Industries Inc
Sep 10, 2015	Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ...	Sterility of device is compromised due to breach in the packaging	Class II	Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015	Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ...	Sterility of device is compromised due to breach in the packaging	Class II	Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015	MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICr...	Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi...	Class II	Beckman Coulter Inc.
Sep 10, 2015	Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ...	Sterility of device is compromised due to breach in the packaging	Class II	Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015	SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac ...	Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed...	Class II	Biosense Webster, Inc.
Sep 9, 2015	ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vit...	Incorrect tubing.	Class II	Abbott Laboratories, Inc
Sep 9, 2015	Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical...	B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ...	Class II	Intuitive Surgical, Inc.
Sep 8, 2015	Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine...	The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated...	Class II	Stryker Spine
Sep 8, 2015	Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis...	Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion ...	Class II	Stryker Howmedica Osteonics Corp.
Sep 8, 2015	Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The S...	DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Int...	Class II	DePuy Orthopaedics, Inc.
Sep 8, 2015	Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053...	Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling...	Class II	ErgoSafe Products, LLC (DBA) Prism Medical
Sep 8, 2015	Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CM...	Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typica...	Class II	Biocare Medical, LLC
Sep 8, 2015	Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; w...	Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling...	Class II	ErgoSafe Products, LLC (DBA) Prism Medical
Sep 6, 2015	Philips Healthcare Ingenuity CT Computed Tomography X-Ray System	Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d...	Class II	Philips Healthcare
Sep 6, 2015	Philips Healthcare Ingenuity Core Computed Tomography X-Ray System	Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d...	Class II	Philips Healthcare
Sep 6, 2015	Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System	Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d...	Class II	Philips Healthcare
Sep 6, 2015	Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System	Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d...	Class II	Philips Healthcare
Sep 6, 2015	Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System	Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d...	Class II	Philips Healthcare
Sep 6, 2015	Philips Healthcare Brilliance 64 Computed Tomography X-Ray System	Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d...	Class II	Philips Healthcare
Sep 6, 2015	Philips Healthcare Brilliance iCT Computed Tomography X-Ray System	Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d...	Class II	Philips Healthcare
Sep 5, 2015	ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: ...	Due to a communication error between the software and V5Ms transducers rotation function, ACUSON ...	Class II	Siemens Medical Solutions USA, Inc.
Sep 4, 2015	5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Uni...	This product was produced using a finishing process not identified as part of the manufacturing s...	Class II	Synthes (USA) Products LLC
Sep 4, 2015	EnVision FLEX/HRP visualization reagent found in the following kits: EnVisio...	There is a defect in one lot of a buffer, non-specific background staining that has, in some inst...	Class II	Dako North America Inc.
Sep 4, 2015	-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipe...	The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices...	Class II	Micro Therapeutics Inc, Dba Ev3 Neurovascular
Sep 3, 2015	Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Na...	In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged oute...	Class II	Zimmer Gmbh
Sep 3, 2015	AMSCO 400 and AMSCO C Small Steam Sterilizers	In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadver...	Class III	Steris Corporation
Sep 3, 2015	Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochem...	These Lot numbers are not stable up to the expiry date on the product labeling.	Class II	Leica Microsystems, Inc.
Sep 3, 2015	Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80...	When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and i...	Class II	Spacelabs Healthcare Inc
Sep 3, 2015	Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC s...	under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack c...	Class II	Roche Diagnostics Operations, Inc.
Sep 3, 2015	AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm...	Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog #...	Class II	Summit Medical, Inc.
Sep 3, 2015	BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biot...	The firm determined that 25 lots had been manufactured with a minor surface defect occurring in t...	Class II	Bausch & Lomb Inc Irb
Sep 3, 2015	Inserter for Titanium Elastic Nails (TEN), orthopedic device	potential for mechanical failures such as breakage.	Class II	Synthes (USA) Products LLC
Sep 1, 2015	IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IM...	Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not produc...	Class II	AGFA Healthcare Corp.
Sep 1, 2015	Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performin...	An issue with a USB memory component contained within a subset of CryoConsoles can result in exte...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Sep 1, 2015	CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Elect...	Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains ...	Class III	CooperSurgical, Inc.
Aug 31, 2015	ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) ...	May contain small amounts of ethylene glycol residue	Class II	ConforMIS, Inc.
Aug 31, 2015	ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog ...	May contain small amounts of ethylene glycol residue	Class II	ConforMIS, Inc.
Aug 31, 2015	Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a param...	Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectl...	Class II	Beckman Coulter Inc.
Aug 31, 2015	GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for di...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT...	May contain small amounts of ethylene glycol residue	Class II	ConforMIS, 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.