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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

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

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DateProductReasonClassFirm
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be us... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone ... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... Product labeling contains incorrect expiration date Class II Medtronic Neurosurgery
Jun 28, 2023 Legion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone c... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 Centurion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extension... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 27, 2023 Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 hole... Thread form issue of the locking holes in that the locking screws would not properly mate with th... Class II Zimmer, Inc.
Jun 26, 2023 Fargo Ortho-K Lens Manufactured lenses are not covered by existing FDA approval Class II PARAGON VISION SCIENCES, Inc
Jun 26, 2023 ISee Ortho-K Lens Manufactured lenses are not covered by existing FDA approval Class II PARAGON VISION SCIENCES, Inc
Jun 26, 2023 Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software Software issue Class II Digisonics, Inc
Jun 23, 2023 Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecol... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 23, 2023 SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used ... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, use... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provi... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 ellacor System with Micro-Coring Technology-Indicated for use by medical prof... Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y ... Class II Cytrellis Biosystems, Inc.
Jun 23, 2023 TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿... There is an improperly performed weld between the cone of the sheath lock and tube of the obturat... Class II Scholly Fiberoptic Gmbh
Jun 23, 2023 YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provid... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 23, 2023 SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to p... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 23, 2023 LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov... During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... Class II Datascope Corp.
Jun 22, 2023 STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... Class II Scican Ltd.
Jun 22, 2023 INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE C... The C-arm, used to set the position and angle of the x-ray exposure field, may not function due t... Class II Canon Medical System, USA, INC.
Jun 22, 2023 Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion... Non-conforming product may appear in the field as inability to advance or retract the basket, or ... Class II Wilson-Cook Medical Inc.
Jun 22, 2023 Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access Three lots of product may be labeled with an incorrect expiration day Class II Creganna Medical Devices
Jun 22, 2023 Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion ... Non-conforming product may appear in the field as inability to advance or retract the basket, or ... Class II Wilson-Cook Medical Inc.
Jun 22, 2023 STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... Class II Scican Ltd.
Jun 21, 2023 HoverMatt, 39" W x 78" L, REF: HM39SPU-B 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there... Class II Stryker Sustainability Solutions
Jun 21, 2023 Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in... (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which sh... Class II Randox Laboratories Ltd.
Jun 21, 2023 A901 Communication Manager Application, used in conjunction with the A710 Cli... When an update to the A710 Clinician Programmer software application for the Intellis Neurostimul... Class II Medtronic Neuromodulation
Jun 20, 2023 Ringed DxI Reaction Vessels (RVs) Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immuno... Class II Beckman Coulter, Inc.
Jun 19, 2023 ARTIS icono biplane -Angiography systems developed for single and biplane dia... Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... Class II Siemens Medical Solutions USA, Inc
Jun 19, 2023 ARTIS icono floor-Angiography systems developed for single and biplane diagno... Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... Class II Siemens Medical Solutions USA, Inc
Jun 19, 2023 GEM FLOW COUPLER Monitor, PN 5156-00000-011 An issue was identified where the LCD monitor display may not indicate the correct active channel... Class II Baxter Healthcare Corporation
Jun 19, 2023 ARTIS pheno-Angiography systems developed for single and biplane diagnostic i... Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... Class II Siemens Medical Solutions USA, Inc
Jun 19, 2023 ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to gui... Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request Class II Materialise N.V.
Jun 16, 2023 CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO 30mm screws were labeled as 25mm screws. Class II Conformis, Inc.
Jun 16, 2023 NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V1146... Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regard... Class II Cardinal Health 200, LLC
Jun 15, 2023 DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also ser... Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the dev... Class II Invacare Corporation

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.