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 9, 2015	miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Han...	Update to labeling for the miraDry Console to remind users to only use approved lubricants in a t...	Class II	Miramar Labs, Inc.
Oct 9, 2015	RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev...	Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque...	Class I	Boston Scientific Corporation
Oct 9, 2015	RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev...	Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque...	Class I	Boston Scientific Corporation
Oct 8, 2015	Merge OrthoCase software. The firm name on the label is Merge Healthcare, H...	Measurements in the software are changing after saving a plan with a measurement result, which ma...	Class II	Merge Healthcare, Inc.
Oct 8, 2015	Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 t...	These lots of Oxygen Dial Regulators could have the settings label off by one position. When the ...	Class II	Precision Medical, Inc.
Oct 8, 2015	Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/...	The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indi...	Class II	Synthes (USA) Products LLC
Oct 7, 2015	Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324...	The affected part number and lot listed above is incorrectly etched with the wrong part number an...	Class II	Synthes (USA) Products LLC
Oct 7, 2015	ACUSON SC2000 ultrasound systems model 10433816 Imaging system that pro...	Siemens will provide all customers a new version of system software (VA35E or VB10C depending on ...	Class II	Siemens Medical Solutions USA, Inc.
Oct 7, 2015	Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angi...	Reports of catheter tip splits and or separation. Loss of device function, medical intervention t...	Class I	Cook Inc.
Oct 7, 2015	Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed	Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury wh...	Class II	Hill-Rom, Inc.
Oct 7, 2015	ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical...	Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 7, 2015	Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortme...	A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty c...	Class II	Ivoclar A. G.
Oct 7, 2015	Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106	Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb...	Class II	Cyberonics, Inc
Oct 6, 2015	2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes mod...	Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.	Class II	Synthes (USA) Products LLC
Oct 6, 2015	Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path	Leakage from the inlet port of the 15L Cycler Drainage Bags.	Class II	Baxter Healthcare Corp.
Oct 5, 2015	MAMMOGRAPHY	Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ...	Class II	Avid Medical, Inc.
Oct 5, 2015	Convenience Kits, MOHS "OPENING" PROCEDURE TRAY	Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ...	Class II	Avid Medical, Inc.
Oct 5, 2015	Convenience Kits, MOHS "OPENING" PROCEDURE TRAY	Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ...	Class II	Avid Medical, Inc.
Oct 5, 2015	PEDIATRIC KIDNEY BIOPSY TRAY	Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ...	Class II	Avid Medical, Inc.
Oct 2, 2015	Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting S...	The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrec...	Class II	Welch Allyn Inc
Oct 2, 2015	Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold i...	Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Cathet...	Class III	C.R. Bard, Inc.
Oct 2, 2015	Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF145...	Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential...	Class II	Focus Diagnostics Inc
Oct 1, 2015	Merge Cardio software. Merge Cardio is a system intended to be used to ac...	Reporting feature times out after inactivity for more than an hour sending the user back to the s...	Class II	Merge Healthcare, Inc.
Oct 1, 2015	ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used...	Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the c...	Class I	Hummingbird Med
Oct 1, 2015	Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura...	Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.	Class II	Philips Electronics North America Corporation
Oct 1, 2015	The "Pacifier Activated Lullaby" (PAL) System composed of three major compone...	PAL unit has undergone significant technological changes since the previous 510(k) and labeling i...	Class II	Powers Medical Devices, LLC
Oct 1, 2015	Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000...	The device might fail to detect air in line while infusing the medication Venofer. This may occu...	Class II	WalkMed Infusion, LLC
Sep 30, 2015	Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s...	For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies ...	Class II	O-Two Medical Technologies, Inc.
Sep 30, 2015	Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SM...	Erroneous low results on a small number of reagent wells. There is the potential for under-recove...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 30, 2015	BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 a...	Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.	Class III	Becton, Dickinson and Company, BD Biosciences
Sep 30, 2015	Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.	The C-arm may interfere with the table top under certain circumstances.	Class II	Shimadzu Medical Systems
Sep 29, 2015	Medtronic Achieve Cables, model 990066. The sterile, single use only Electri...	64 units of Achieve Electrical Cables were shipped with a potential sterility breach.	Class II	Medtronic Inc.
Sep 29, 2015	TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811	Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they m...	Class II	Tekia, Inc.
Sep 29, 2015	Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric...	Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ ...	Class I	Alcon Research, Ltd.
Sep 29, 2015	Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, R...	Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints w...	Class II	Stryker Howmedica Osteonics Corp.
Sep 29, 2015	MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate...	The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter scr...	Class II	Biomet Spine, LLC
Sep 28, 2015	Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Su...	Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella ...	Class II	Exactech, Inc.
Sep 28, 2015	VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 85...	The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes ...	Class III	Ortho-Clinical Diagnostics
Sep 28, 2015	Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile...	The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.41...	Class II	Synthes (USA) Products LLC
Sep 28, 2015	The Centricity PACS-IW with Universal Viewer is a device that displays medica...	Inaccurate distance measurements with magnified projection X-ray images.	Class II	GE Healthcare
Sep 28, 2015	ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assess...	An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessmen...	Class II	Varian Medical Systems, Inc.
Sep 28, 2015	The Centricity Universal Viewer Version is a device that displays medical ima...	Inaccurate distance measurements with magnified projection X-ray images.	Class II	GE Healthcare
Sep 25, 2015	MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed...	The pump drive motors may experience a malfunction which would result in a pump error message ala...	Class II	Medtronic MiniMed Inc.
Sep 25, 2015	MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 T...	The pump drive motors may experience a malfunction which would result in a pump error message ala...	Class II	Medtronic MiniMed Inc.
Sep 25, 2015	Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to p...	Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because...	Class II	Stryker Spine
Sep 24, 2015	ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 12...	Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bia...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 24, 2015	Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #W...	Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A...	Class II	Airways Development LLC
Sep 24, 2015	MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.	Display freeze of MODULARIS hand control results in information not being updated on the display....	Class II	Siemens Medical Solutions USA, Inc
Sep 23, 2015	TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for u...	During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to ...	Class II	Berchtold Corp.
Sep 23, 2015	Signature Patient-Specific Surgical Guides; patient specific instruments used...	Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because ...	Class II	Materialise N.V.

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.