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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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Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 1, 2023 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DUR PCA MTK REV INS LFT Intended for knee replacement Product N... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Nov 30, 2023 BrightView X, Gamma Camera, Product Code 882478 While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... Class II Philips North America
Nov 30, 2023 Link Patella Glide Resection Guide- For the implantation of the Endo-Model Kn... Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dim... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Nov 30, 2023 BrightView, Gamma Camera System, Product Code 882480. While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... Class II Philips North America
Nov 30, 2023 BrightView XCT, Gamma Camera, Product Code 882482 While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... Class II Philips North America
Nov 30, 2023 Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ... The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generator... Class II Boston Scientific Corporation
Nov 30, 2023 GammaPod - Treatment Planning System-a component of the GammaPod Irradiation ... Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS gen... Class II Xcision Medical Systems, LLC
Nov 30, 2023 bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. Class II B-K Medical A/S
Nov 30, 2023 Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. Multiple software issues that affect device functionality. Class II Philips North America Llc
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) HEAR... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, urological, labeled as: a) U... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, anesthesia, labeled as: a) H... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Ophthalmic use, labeled as: ... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Othopedic use, labeled as: a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) CENT... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 RX Series Copper (Cu) Assay Ref. Number CU2340 Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to deta... Class II Randox Laboratories Ltd.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2... Surgical gowns were manufactured with the wrong sleeve. Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Sensis Vibe Hemo The possibility of the Sensis documentation functionality application to crash. Class II Siemens Medical Solutions USA, Inc
Nov 29, 2023 Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, ear, nose & throat, labeled as:... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 28, 2023 MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray Sy... Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the o... Class II Micro-X Ltd.
Nov 28, 2023 Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to... In rare cases, the lever of the throttle can get temporarily stuck during the movement and does n... Class II mo-Vis BVBA
Nov 28, 2023 Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... Class II AtriCure, Inc.
Nov 28, 2023 VADER pedicle system, torque wrench, Catalog Number 42-702 icotec has received notification of one revision that had to be carried out because nut screws ha... Class II Icotec Ag
Nov 28, 2023 Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws lab... Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorr... Class II XTANT Medical Holdings, Inc
Nov 28, 2023 VADER pedicle system, torque wrench, Catalog Number 42-703 icotec has received notification of one revision that had to be carried out because nut screws ha... Class II Icotec Ag
Nov 28, 2023 (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 Push notifications may fail to send to the user under certain conditions. This could potentially ... Class II Philips North America
Nov 28, 2023 MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femor... Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... Class II Cordis US Corp
Nov 28, 2023 EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... Class II Natus Medical Incorporated
Nov 28, 2023 External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... Class II Natus Medical Incorporated
Nov 28, 2023 Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una... Class II Medtronic Navigation, Inc.
Nov 28, 2023 Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S,... Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop ou... Class II TriMed Inc.
Nov 28, 2023 MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral ... Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... Class II Cordis US Corp
Nov 28, 2023 Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... Class II AtriCure, Inc.
Nov 28, 2023 Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una... Class II Medtronic Navigation, 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.