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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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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

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
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
Sep 18, 2014 Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiratio... The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a sa... Class II Siemens Medical Solutions USA, Inc
Sep 18, 2014 Multi-Lumen Central Venous Catheterization Kit Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot numbe... Class II Arrow International Inc
Sep 17, 2014 Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094... The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not b... Class II Siemens Medical Solutions USA, Inc
Sep 15, 2014 ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidura... Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AF... Class II Arrow International Inc
Sep 2, 2014 Siemens Ysio Max system The Ysio Max is a radiographic system used in hospit... Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... Class II Siemens Medical Solutions USA, Inc
Sep 2, 2014 DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm par... DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Pl... Class II Synthes, Inc.
Sep 2, 2014 Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detecto... Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... Class II Siemens Medical Solutions USA, Inc
Sep 2, 2014 Siemens Luminos Agile Max system The Luminos Agile is intended to be used a... Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... Class II Siemens Medical Solutions USA, Inc
Sep 2, 2014 Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to... Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... Class II Siemens Medical Solutions USA, Inc
Aug 28, 2014 Bionector Needleless connector. Bionector is a multi-purpose catheter accesso... Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needlel... Class II Vygon Corporation
Aug 27, 2014 The Ysio Systems with software version VC10 The Ysio enables radiographic ... Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the... Class II Siemens Medical Solutions USA, Inc
Aug 12, 2014 AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Lum... It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 o... Class II Siemens Medical Solutions USA, Inc
Aug 12, 2014 eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA... Two (2) failures of the spring link components within the articulated arm assembly. The spring li... Class II Gendex Corp
Aug 6, 2014 B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices... The primary packaging label (inner pouch label) indicates that the package contents are Catalog I... Class II B. Braun Medical, Inc.
Aug 6, 2014 Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Me... The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline F... Class II Arrow International Inc
Aug 4, 2014 Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is i... The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. Class II Medical Components, Inc dba MedComp
Jul 30, 2014 Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container ... Integra LifeSciences has identified through an internal investigation that some colored lids for ... Class II Integra York PA, Inc
Jul 7, 2014 Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF ... It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia ... Class II Siemens Medical Solutions USA, Inc
Jul 1, 2014 Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. ... The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP ... Class II Ansar Group, Inc. Dba Ansar Medical Technologie...
Jun 30, 2014 Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set A screw set was returned from the field for destruction after being exposed to flood water, which... Class II Synthes, 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.