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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

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

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Clear
DateProductReasonClassFirm
Jan 18, 2013 Elekta, Apex add-on Micro MLC, collimator for radiation therapy. If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activ... Class II Elekta, Inc.
Jan 17, 2013 SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; Sybr... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Jan 17, 2013 SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; ... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Jan 17, 2013 KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Mod... Missing symbols and manufacturing information on the clear carton label. The expiration dating s... Class III Carestream Health, Inc.
Jan 17, 2013 SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Pa... Siemens became aware of a potential safety issue when using the "In-session resumption" feature o... Class II Siemens Medical Solutions USA, Inc
Jan 16, 2013 Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table ... Class II Philips Healthcare Inc.
Jan 16, 2013 Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Uni... The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for si... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Nu... An inspection shows several IATDs (Installation Acceptance Test could not be located or different... Class II Philips Healthcare Inc.
Jan 16, 2013 Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Model... A consumer complaint that a catheter was observed to be in several pieces under patient fluorosco... Class II Merit Medical Systems, Inc.
Jan 16, 2013 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY ... Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Sm... Class II Greatbatch Medical
Jan 16, 2013 Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation A... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032... An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) recor... Class II Philips Healthcare Inc.
Jan 15, 2013 Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Worksta... A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may caus... Class I Del Mar Reynolds Medical, Ltd.
Jan 15, 2013 Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos... Siemens has become aware of a potential malfunction and possible hazard to patients and staff whe... Class II Siemens Medical Solutions USA, Inc
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. D... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. ... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Del... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 14, 2013 P10 Tobii battery box (product number 510410) Product Usage - Battery pack... Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunc... Class II Tobii Assistive Technology, Inc.
Jan 14, 2013 BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 14, 2013 Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 ... VS2+ screen may lock up and stop monitoring during patient use Class II Philips Healthcare Inc.
Jan 14, 2013 GE Healthcare Senographe Essential System. The Senographe 2000D system gen... GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instruc... Class II GE Healthcare, LLC
Jan 14, 2013 BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 14, 2013 LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healt... Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condo... Class II Ansell Healthcare Products LLC
Jan 14, 2013 Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400.... Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, i... Class II Oxus America, Inc.
Jan 14, 2013 Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate... Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labe... Class II Atricure Inc
Jan 11, 2013 Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number ... This recall is being initiated in response to complaints received where it was reported that the ... Class II Synthes USA HQ, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Large Combination Clamp/Large External Fixation System, Part Number 390.005 ... The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm socket... Class II Synthes USA HQ, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. Fo... There is the potential for the anterior footplates to not fit onto the Titanium Midface Distracto... Class II Synthes USA HQ, Inc.
Jan 11, 2013 Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Par... It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... Class II Synthes USA HQ, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Flexible Grip which is part of the Synthes Universal Nail System. Indicate... Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part ... Class II Synthes USA HQ, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular ... It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... Class II Synthes USA HQ, Inc.
Jan 11, 2013 Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, P... It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Pa... Class II Synthes USA HQ, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc.... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Par... It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... Class II Synthes USA HQ, 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.