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Vehicle Safety

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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.

Clear
DateProductReasonClassFirm
Jun 12, 2015 Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic. QC results were out of range resulting in false resistant strains. Class II BioMerieux SA
Jun 12, 2015 ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation S... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articul... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 GE Healthcare Precision RXi 23A/32A Analog System A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and D... Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports ... Class II Medtronic Perfusion Systems
Jun 12, 2015 ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Art... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 OxySure Model 615 disposable replacement cartridges, for portable oxygen gene... Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimu... Class II Oxysure Systems, Inc.
Jun 12, 2015 ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement ... Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring ... Class II CryoLife, Inc.
Jun 12, 2015 ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. There is potential risk of electrical shock if lead wires inside the device become detached and t... Class II MicroAire Surgical Instruments, LLC
Jun 12, 2015 GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Flu... The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This m... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision 500D Classical R & F system. A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 11, 2015 JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed ... JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may de... Class II Justright Surgical, LLC
Jun 11, 2015 SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and... During certain clinical workflows safety issues may occur involving monitor assignment order and ... Class II Siemens Medical Solutions USA, Inc
Jun 11, 2015 ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARC... The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the pote... Class II Abbott Laboratories
Jun 11, 2015 JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed... JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may de... Class II Justright Surgical, LLC
Jun 10, 2015 Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed ... Class II ASO, LLC
Jun 10, 2015 Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intend... The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversiz... Class II Synthes (USA) Products LLC
Jun 10, 2015 NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgi... Inadequate curing of adhesive, may cause the two halves of the spheres to separate. Class II Northern Digital Inc.
Jun 10, 2015 Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Ar... There is a potential issue that could result to collision between the C-arm of the angiography sy... Class II Maquet Cardiovascular Us Sales, Llc
Jun 9, 2015 Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product U... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically,... Class II Omnilife Science Inc.
Jun 9, 2015 Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Us... The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically,... Class II Omnilife Science Inc.
Jun 9, 2015 Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta... Higher than published scatter around the probe head when testing some samples. At the point the c... Class II Olympus Scientific Solutions Americas
Jun 9, 2015 Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Gui... Inadequate interference between the screw and the plate when screw implanted into the plate at an... Class II Alliance Partners LLC
Jun 8, 2015 Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX4... Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired... Class II Allergan Inc
Jun 5, 2015 Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStar... Multiple software and hardware issues with device that can affect its function. Class II Philips Electronics North America Corporation
Jun 5, 2015 Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear N... Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736... Class II Cochlear Americas Inc.
Jun 4, 2015 APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-1... The device may have improper screw hole placement due to inaccurate location of the index line. Class II Omnilife Science Inc.
Jun 4, 2015 Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano... During a relabeling procedure at the manufacturing facility, the products were labeled with a she... Class II Volcano Corporation
Jun 4, 2015 THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage... Vacuum pump may not perform to specification. Class II Gardner Denver Thomas Inc
Jun 4, 2015 THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage... Vacuum pump may not perform to specification. Class II Gardner Denver Thomas Inc
Jun 4, 2015 Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-... Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled... Class II Merit Medical Systems, Inc.
Jun 4, 2015 SOMATOM Emotion 6; produce cross-sectional images of the body by computer rec... A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix ... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2015 SOMATOM Emotion 16; produce cross-sectional images of the body by computer re... A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix ... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2015 Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Presti... During a relabeling procedure at the manufacturing facility, the products were labeled with a she... Class II Volcano Corporation
Jun 4, 2015 A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. Class II Biomet, Inc.
Jun 4, 2015 THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage... Vacuum pump may not perform to specification. Class II Gardner Denver Thomas Inc
Jun 4, 2015 A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedi... The thread location on one of the thread holes is offset from the axis of the predrill hole. The ... Class II Biomet, Inc.
Jun 4, 2015 Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take pan... Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. Class II Panoramic Rental Corp.
Jun 3, 2015 Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill gui... Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an i... Class II Biomet, Inc.
Jun 3, 2015 WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wi... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamm... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF ... The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... Class II Smith & Nephew, Inc.
Jun 3, 2015 Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF... The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... Class II Smith & Nephew, Inc.
Jun 3, 2015 TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL... A specific part and lot number was packaged and shipped prior to the completion of a required int... Class II Synthes, Inc.
Jun 3, 2015 Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The ... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer

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.