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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
Oct 10, 2012 MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ce... A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 ... Class II Siemens Medical Solutions USA, Inc
Oct 10, 2012 Siemens Mobilette Mira, intended use as Mobile x-ray system. There is a risk of lost images during examination. Class II Siemens Medical Solutions USA, Inc
Oct 5, 2012 Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP... Under certain conditions, when using the Search functionality, the potential exists for the wrong... Class II Siemens Medical Solutions USA, Inc
Sep 28, 2012 Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. ... The insert provided with the product for the specific lot number indicates that this product is M... Class II Synthes USA HQ, Inc.
Sep 12, 2012 Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic R... When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as i... Class II Siemens Medical Solutions USA, Inc
Sep 7, 2012 Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; ... Firm initiated an update to Directions for Use necessitating replacement of previously distribute... Class II Instrumentation Industries Inc
Sep 7, 2012 Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part ... This action is being initiated following a detailed investigation in response to reported complai... Class II Synthes USA HQ, Inc.
Sep 7, 2012 Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bo... This action is being initiated following a detailed investigation in response to reported complai... Class II Synthes USA HQ, Inc.
Aug 21, 2012 Siemens Mobilett Mira. Mobile X-Ray System. During regular product monitoring, Siemens has become aware of a potential issue with the Mobilet... Class II Siemens Medical Solutions USA, Inc
Aug 6, 2012 Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating fo... Although the reported incidence is low, there is the potential for the drill stop to slip on the ... Class II Synthes USA HQ, Inc.
Aug 6, 2012 Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating fo... Although the reported incidence is low, there is the potential for the drill stop to slip on the ... Class II Synthes USA HQ, Inc.
Jul 30, 2012 DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 throu... A condition can occur during renumbering of the patient database using the DEXCopy feature. When... Class II Imaging Sciences International, LLC
Jul 26, 2012 Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical ... When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in t... Class II Stryker Orthobiologics, Inc.
Jul 25, 2012 Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, S... There is a possibility that the screw channel that holds the rod in place may be out of tolerance... Class II Aesculap Implant Systems LLC
Jul 24, 2012 Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended ... Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22,... Class II Capintec Inc
Jul 18, 2012 syngo Imaging XS. Radiological image processing system. There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some s... Class II Siemens Medical Solutions USA, Inc
Jul 18, 2012 syngo.plaza, Model number 10592457. Intended use: radiological image proc... There is a potential malfunction in which a miscalculation occurs for images with pixel depth val... Class II Siemens Medical Solutions USA, Inc
Jul 16, 2012 IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump gluco... Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad f... Class II Animas Corporation
Jul 12, 2012 Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree T... The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but ... Class II Aesculap Implant Systems LLC
Jul 5, 2012 Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S... There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical caut... Class I Synthes USA HQ, Inc.
Jul 2, 2012 Drager PT 4000 Phototherapy System A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with... Class II Draeger Medical Systems, Inc.
Jun 20, 2012 Siemens syngo.plaza Radiological Image Processing System Usage: Radiologic... Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instr... Class II Siemens Medical Solutions USA, Inc
Jun 18, 2012 MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for ... Synthes is initiating a Medical Device Labeling Correction following a detailed review of the cur... Class II Synthes USA HQ, Inc.
Jun 7, 2012 Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Inject... Arrow is recalling the product due to the possibility of voids in the catheter hub which could le... Class II Arrow International Inc
Jun 6, 2012 Siemens syngo.plaza radiological image processing system. Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2012 Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal C... The deflector may not move freely on the ventricular catheter. The deflector comes pre-positione... Class II Aesculap, Inc.
May 31, 2012 Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right ... USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong pa... Class II Synthes (USA) Products LLC
May 22, 2012 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 22, 2012 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL F... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefil... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10m... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefill... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Pr... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10m... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes in... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 9, 2012 Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) The manufacturer informed the recalling firm of a potential laser marking error in size identific... Class II Aesculap, Inc.
May 3, 2012 Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROW... Lidstock of product does not contain chlorhexidine contraindication and contains wording "contain... Class I Arrow International Inc
Apr 30, 2012 Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray s... During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira ... Class II Siemens Medical Solutions USA, Inc
Apr 30, 2012 Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Urosk... Class II Siemens Medical Solutions USA, Inc
Apr 27, 2012 Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy ... The specified Trilogy units are being recalled because of the potential for a faulty component in... Class I Respironics, Inc.
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump Syst... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for ... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristalti... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad Inc
Apr 18, 2012 Medrad(R) Continuum MR Infusion System Standard Administration Kit Perista... Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... Class II Medrad 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.