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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

2,939 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,939 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 2,939 FDA device recalls in PA.

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DateProductReasonClassFirm
Jan 21, 2015 Siemens LANTIS Oncology Information System Servers; allows the radiation the... There is a potential safety risk when using LANTIS server software with operating systems with wh... Class II Siemens Medical Solutions USA, Inc
Jan 16, 2015 Artis One; The Artis One is an angiography system developed for diagnostic in... The possibility exists that the monitor may fail and requires a power circle (shutdown and then p... Class II Siemens Medical Solutions USA, Inc
Jan 13, 2015 Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PAC... In case of a system crash, images may not be written to the hard disk and this may result in inco... Class II Siemens Medical Solutions USA, Inc
Jan 13, 2015 GE Inspection Technologies x|argos 160D system. Cabinet x-ray system. It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... Class II GE Inspection Technologies, LP
Jan 13, 2015 GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... Class II GE Inspection Technologies, LP
Jan 9, 2015 Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial ... Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the inco... Class III Arrow International Inc
Jan 5, 2015 ARROW Epidural Needle Component (product number AN-05501). Epidural needles ... The product labeling does not specify the 5 year shelf life of the product. Class II Arrow International Inc
Jan 2, 2015 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lume... Foreign material found within the kits. The foreign material, white or black particles and/or thr... Class II Arrow International Inc
Jan 2, 2015 Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR a... Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registrat... Class II Siemens Medical Solutions USA, Inc
Dec 29, 2014 Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distribu... Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Tabl... Class II Dick's Sporting Goods
Dec 19, 2014 LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR ... A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent prot... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2014 Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is in... In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric... Class II Synthes, Inc.
Dec 17, 2014 Miethke Shunt System accessories Product Usage: - The Miethke Shunt Syst... Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box lab... Class II Aesculap, Inc.
Dec 16, 2014 Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POS... the Instructions for Use (IFU) were inadvertently removed from the kit. Class II Arrow International Inc
Dec 15, 2014 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Int... Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is... Class II Synthes, Inc.
Dec 15, 2014 Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 an... Potential for composed images to be flipped before being sent to PACS on systems with software v... Class II Siemens Medical Solutions USA, Inc
Dec 15, 2014 Malleable C- Retractor, Part Number 397.232, used to provide retraction of th... Potential failure and/or corrosion of the internal spring of the retractor, which may have been m... Class II Synthes, Inc.
Dec 12, 2014 R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube... Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal... Class II Teleflex, Inc.
Dec 4, 2014 Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: ... There is the potential for a breach in the inner or outer packaging pouches of all lots of the Im... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Dec 4, 2014 Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Number... There is the potential for a breach in the inner or outer packaging pouches of all lots of the St... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Dec 4, 2014 MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-81... Connector mount cracks which may lead to a leak failure during use and necessitate immediate repl... Class I Teleflex, Inc.
Dec 3, 2014 Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: ... Suboptimal routing of the cable may result in increased wear over time. Without additional measur... Class II Siemens Medical Solutions USA, Inc
Dec 3, 2014 SOMATOM Force; the intended use of computed tomography is to produce cross-se... Artifacts are found in acquired imaging on the SOMATOM Force. Class II Siemens Medical Solutions USA, Inc
Dec 2, 2014 Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus... Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator ... Class II Siemens Medical Solutions USA, Inc
Dec 1, 2014 EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Kne... Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition wher... Class II Stelkast Co
Nov 21, 2014 Tracheopart Set (Left), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 White Bronchial Double Lumen Tube Set (Right) Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 Tracheopart Set (Right), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 Bronchial One Lumen Tube - Right Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 Bronchial Double Lumen Tube Set (Left), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 Bronchial One Lumen Tube - Left Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 Bronchial Double Lumen Tube Set (Right), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 21, 2014 Carlens Bronchial Double Lumen Tube Set (Left) Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class II Teleflex, Inc.
Nov 19, 2014 ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The... There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mAR... Class II Siemens Medical Solutions USA, Inc
Nov 11, 2014 Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int... Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p... Class III Aesculap, Inc.
Nov 11, 2014 Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: ... Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS ... Class II Siemens Medical Solutions USA, Inc
Nov 10, 2014 GE Cabinet X-ray systems GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray Sys... Class II GE Inspection Technologies, LP
Nov 10, 2014 Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of c... Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-... Class II Arrow International Inc
Nov 10, 2014 GE Optional Laser Centering Device X-ray generator. GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 f... Class II GE Inspection Technologies, LP
Nov 6, 2014 Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electr... The device may operate solely in reverse mode, not operate in reverse mode when intended, not fun... Class II Synthes (USA) Products LLC
Oct 29, 2014 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Ster... The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assemble... Class II Synthes, Inc.
Oct 28, 2014 Mammomat Inspiration system: Product Usage: mammography exams, screening... It was determined that if the Mammomat Inspiration system is not secured to the floor (per custom... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2014 The Dual Switch Valve is used for fluid drainage from the ventricles into the... Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to i... Class II Aesculap, Inc.
Oct 23, 2014 Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: T... Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws... Class I Synthes (USA) Products LLC
Oct 17, 2014 The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 ... Under new testing protocols for MR Environment safety and compatibility, metal devices are no lon... Class II Synthes, Inc.
Oct 10, 2014 Siemens SimView NT and SimView NT with IDI simulation system components: ... Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simul... Class II Siemens Medical Solutions USA, Inc
Oct 2, 2014 DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 Particle residue on the instrument from adhesive tape which was used to bind the device during tr... Class II Synthes, Inc.
Oct 1, 2014 APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plate... A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of... Class II Medartis, Inc.
Sep 23, 2014 Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : A... A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routi... Class II Siemens Medical Solutions USA, 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.