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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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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DateProductReasonClassFirm
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut... Class II Abbott Medical Optics Inc. (AMO)
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. ... If metal strips are removed and re-applied to another display, there is potential for the metal s... Class II Barco N.V.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 Dressing Rect L, P/N 02428 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Shldr, P/N 04908 Product Usage: These products are sterile dress... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 18L6 HD transducer on the ACUSON S Family ultrasound systems with software ve... When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the u... Class II Siemens Medical Solutions USA, Inc.
Mar 30, 2017 Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Back, P/N 09810 Product Usage: These products are sterile dressi... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dr... They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... Class II Breg Inc
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 29, 2017 Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number... High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... Class II Volcano Corporation
Mar 29, 2017 Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Prod... High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... Class II Volcano Corporation
Mar 29, 2017 Medi-Therm Hyper/Hypothermia System, MTA7900 The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to... Class II Stryker Medical Division of Stryker Corporation
Mar 29, 2017 Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. Class III Teleflex Medical
Mar 28, 2017 Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio F... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAM... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 28, 2017 Artis zee, Angiographic x-ray system Software error - As a result of a software fault in Artis zee systems with software version VD11 ... Class II Siemens Medical Solutions USA, Inc
Mar 28, 2017 GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAM... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 28, 2017 MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 P... It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire inste... Class II Bard Peripheral Vascular Inc
Mar 28, 2017 GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.D... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 28, 2017 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frame... Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construc... Class II Mizuho OSI
Mar 27, 2017 Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblag... Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated th... Class II Alcon Research, Ltd.
Mar 27, 2017 Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Impl... Missing Dome Pack accessory. Class II Mentor Texas, LP.
Mar 24, 2017 Legacy Base for Dual Bed Configurations A potential for dual-configured beds to separate or slip away from one another. Class II Craftmatic Industries, Inc.
Mar 24, 2017 Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Sta... ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not ... Class II Dale Medical Products, Inc.
Mar 24, 2017 Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale S... ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not ... Class II Dale Medical Products, Inc.
Mar 24, 2017 Craftmatic Model 1 Base for Dual Bed Configurations A potential for dual-configured beds to separate or slip away from one another. Class II Craftmatic Industries, Inc.
Mar 24, 2017 Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel,... Confirmed complaint of surface contamination of Listeria monocytogenes. Class II Remel Inc
Mar 24, 2017 Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5... Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, ... Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visi... Class II Teleflex Medical
Mar 23, 2017 Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column a... Elevating Monitor Suspension column dropping and will not rise back up. Class II Omega Medical Imaging, Inc.
Mar 23, 2017 1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K... Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a... Class II Merit Medical Systems, Inc.
Mar 23, 2017 Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is in... It was discovered during a procedure that when the operator made an exposure on the wireless x-ra... Class II Toshiba American Medical Systems
Mar 23, 2017 Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wa... Reported customer complaints of automated hematology analyzers catching fire due to misalignment ... Class II Sysmex America Inc
Mar 22, 2017 AIA-360 Analyzer is capable of performing two methods of immunoassay: an immu... The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the t... Class II Tosoh Bioscience 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.