Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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Date	Product	Reason	Class	Firm
Oct 13, 2017	Amplatz Ultra Stiff Wire Guide	Label does not state that the product is heparin-coated.	Class II	Cook Inc.
Oct 13, 2017	Amplatz Extra Stiff Wire Guide	Label does not state that the product is heparin-coated.	Class II	Cook Inc.
Oct 13, 2017	Movable Core Wire Guide	Label does not state that the product is heparin-coated.	Class II	Cook Inc.
Oct 13, 2017	Coons Interventional Wire Guide	Label does not state that the product is heparin-coated.	Class II	Cook Inc.
Oct 12, 2017	Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Si...	This voluntary recall is being conducted due to the potential for failure to detect the affected...	Class II	Covidien LLC
Oct 11, 2017	Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1	Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assem...	Class II	GE Medical Systems China Co., Ltd.
Oct 11, 2017	Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2	Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assem...	Class II	GE Medical Systems China Co., Ltd.
Oct 11, 2017	TunneLoc Tibial Fixation Device Product Usage: To provide fixation of sof...	Gamma sterilization validation testing indicates the sterilization dose for the product may not b...	Class II	Zimmer Biomet, Inc.
Oct 11, 2017	VITEK2 GP-ID, REF 21342 IVD	Customers have reported, and an internal investigation has confirmed, occurrences of atypical neg...	Class II	Biomerieux Inc
Oct 11, 2017	Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic...	The device may contain a manufacturing condition affecting the geometry of the driver's hex featu...	Class II	Zimmer Dental Inc
Oct 11, 2017	Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ...	Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical venti...	Class I	Spacelabs Healthcare, Ltd.
Oct 11, 2017	TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To pro...	Gamma sterilization validation testing indicates the sterilization dose for the product may not b...	Class II	Zimmer Biomet, Inc.
Oct 11, 2017	Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic...	The device may contain a manufacturing condition affecting the geometry of the driver's hex featu...	Class II	Zimmer Dental Inc
Oct 11, 2017	Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref...	The device may contain a manufacturing condition affecting the geometry of the driver's hex featu...	Class II	Zimmer Dental Inc
Oct 11, 2017	Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manu...	The device may contain a manufacturing condition affecting the geometry of the driver's hex featu...	Class II	Zimmer Dental Inc
Oct 10, 2017	Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink...	Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so...	Class II	Medtronic Inc.
Oct 10, 2017	ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implan...	One reported complaint and discovered that the outer vial was out of round and undersized. There...	Class II	Implant Direct Sybron Manufacturing, LLC
Oct 10, 2017	MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8	Products labeled as sterile were distributed prior to sterilization	Class II	Medline Industries Inc
Oct 10, 2017	MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHE...	Products labeled as sterile were distributed prior to sterilization	Class II	Medline Industries Inc
Oct 10, 2017	Crimson Trace Corporation laser sights. The Finished Products are laser si...	A previously "in specification" Finished Product with a Model 25-0657 diode had power output high...	Class II	Crimson Trace Corporation
Oct 10, 2017	STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (out...	The label outside the cardboard box is labeled correctly but the pouches inside of some of the bo...	Class II	Karl Storz Endoscopy
Oct 10, 2017	SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-...	Following the identification of corrosion residue found inside the cannulated devices in Forefoot...	Class II	ORTHO SOLUTIONS, LTD.
Oct 9, 2017	Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 10...	Cepheid has received reports that some of our customers have experienced a higher number of temp...	Class II	Cepheid
Oct 9, 2017	Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Co...	Wrong device description of the label identifying the implant	Class II	Exactech, Inc.
Oct 9, 2017	PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S	Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demon...	Class II	Inovo, Inc
Oct 6, 2017	Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz...	The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a ...	Class II	CooperSurgical, Inc.
Oct 6, 2017	Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intende...	Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port...	Class II	Medimop Medical Projects Ltd.
Oct 6, 2017	Philips Ingenuity Core 128 computed tomography x-ray system	Numerous issues related to software Brilliance iCT 4.1.6 software version.	Class II	Philips Medical Systems (Cleveland) Inc
Oct 6, 2017	Philips Ingenuity CT computed tomography x-ray system	Numerous issues related to software Brilliance iCT 4.1.6 software version.	Class II	Philips Medical Systems (Cleveland) Inc
Oct 6, 2017	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTI...	Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lu...	Class II	Baxter Healthcare Corporation
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 via...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. ...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet ...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Allen Medical Bow Frame Model A-70800. Surgical platform used to position pa...	The base of the frame has the potential to crack when the patient is initially transferred to the...	Class II	Allen Medical Systems
Oct 6, 2017	NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet P...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet P...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Philips Ingenuity Core computed tomography x-ray system	Numerous issues related to software Brilliance iCT 4.1.6 software version.	Class II	Philips Medical Systems (Cleveland) Inc
Oct 6, 2017	Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 ...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials p...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position...	The base of the frame has the potential to crack when the patient is initially transferred to the...	Class II	Allen Medical Systems
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 via...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Philips Brilliance 64 computed tomography x-ray system	Numerous issues related to software Brilliance iCT 4.1.6 software version.	Class II	Philips Medical Systems (Cleveland) Inc
Oct 5, 2017	2008T, Hemodialysis Delivery System Product Indicated for acute and chroni...	While reviewing documentation for the next software release of the 2008T, an R&D technician ident...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Oct 5, 2017	Philips Network Firewall (Cisco ASA 5506), Model # 867098	Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic ma...	Class II	Philips Electronics North America Corporation
Oct 5, 2017	WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF...	The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.	Class II	Teleflex Medical
Oct 5, 2017	MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.	The firm received complaints that involved an unanticipated interaction between a NeuroBlate syst...	Class I	Monteris Medical Corp
Oct 4, 2017	INFINITY DUAL HEMO MCable Pod	Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinit...	Class II	Draegar Medical Systems, Inc.
Oct 4, 2017	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered deliv...	Non-Conforming devices were shipped from the service center without proper evaluation and therefo...	Class II	GE Healthcare, LLC
Oct 4, 2017	VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therap...	The devices have an incorrect firmware configuration.	Class II	Boston Scientific 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.