Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Oct 13, 2016 IQon Spectral CT Computed Tomography X-ray system, Model 728332 The product label does not include the correct current rating. Class III Philips Medical Systems (Cleveland) Inc
Oct 13, 2016 Brilliance ICT SP Computed Tomography X-ray system, Model 728311 The product label does not include the correct current rating. Class III Philips Medical Systems (Cleveland) Inc
Oct 13, 2016 Ingenuity Core Computed Tomography X-ray system, Model 728321 The product label does not include the correct current rating. Class III Philips Medical Systems (Cleveland) Inc
Oct 13, 2016 BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covingt... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, Inc.
Oct 13, 2016 Brilliance iCT Computed Tomography X-ray system, Model 728306 The product label does not include the correct current rating. Class III Philips Medical Systems (Cleveland) Inc
Oct 13, 2016 Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Co... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, Inc.
Oct 6, 2016 Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophy... The EP Catheters may be mislabeled for French size during reprocessing. Class II Stryker Sustainability Solutions
Oct 5, 2016 Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box),... Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instea... Class II C.R. Bard, Inc.
Oct 3, 2016 Medtronic SynchroMed II Implantable Drug Infusion System. This system includ... Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th... Class I Medtronic Neuromodulation
Sep 29, 2016 Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 1... The insert and case label description of the device incorrectly reads Counter Incrementing Actuat... Class II Thayer Medical Corporation
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class II Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 25, 2016 Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the di... Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... Class III Acumedia Manufacturers, Inc.
Sep 19, 2016 VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporizat... FDA inspection found that customers who had received devices with promotional material with outs... Class II New Star Lasers, Inc.
Sep 19, 2016 CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermato... FDA inspection found that customers who had received devices with promotional material with outs... Class II New Star Lasers, Inc.
Sep 19, 2016 ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, exc... FDA inspection found that customers who had received devices with promotional material with outs... Class II New Star Lasers, Inc.
Sep 12, 2016 Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by e... A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. Class II A & D Enginering Inc
Sep 9, 2016 Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile ... The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... Class II Teleflex Medical
Sep 9, 2016 Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile... The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... Class II Teleflex Medical
Sep 9, 2016 SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum... Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr typ... Class II Akita Sumitomo Bakelite Co., Ltd.
Sep 9, 2016 SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M ... Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type Class II Akita Sumitomo Bakelite Co., Ltd.
Sep 7, 2016 Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the f... The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 7, 2016 ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Dis... Mislabeling of the "expiration date". The expiration date on the outer box and the individual po... Class II Ellman International, Inc.
Sep 2, 2016 HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD th... Labeling inconsistency Class II Arrow International Inc
Sep 2, 2016 Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 ... Screws were identified as having the incorrect part number and lot number marked upon them. The ... Class II Trilliant Surgical Ltd.
Sep 1, 2016 Visualase Body Accessory Kit PN 020-3000. The individual components within th... Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... Class II Medtronic Navigation, Inc.
Sep 1, 2016 Visualase Visualization Stylets PN 020-2301. The individual components within... Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... Class II Medtronic Navigation, Inc.
Aug 31, 2016 Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex X... SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration d... Class II Ormco/Sybronendo
Aug 26, 2016 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 Th... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The pro... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantatio... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, ... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The pro... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantatio... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is ind... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is ... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. ... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 26, 2016 TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product... Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... Class II Abbott Medical Optics Inc. (AMO)
Aug 25, 2016 Merit Inflation Syringe Kit. Catalog Number KOS-02857 Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due... Class II Merit Medical Systems, Inc.
Aug 22, 2016 Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast bi... Incorrect label on the Sertera Biopsy Kit Class II Hologic, Inc
Aug 16, 2016 Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This pro... Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Mor... Class II Zimmer Biomet, Inc.
Aug 10, 2016 Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Produ... Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopot... Class II Blackrock Microsystems, LLC
Aug 10, 2016 Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes withi... Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopot... Class II Blackrock Microsystems, LLC
Aug 9, 2016 Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and... Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal F... Class II Zimmer Biomet, Inc.
Aug 8, 2016 Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Produc... Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage tempe... Class III Acumedia Manufacturers, Inc.
Aug 8, 2016 Arterial Line Catheterization Kit with Sharps Safety Features Permits access... Shipping carton labeling error. Class II Arrow International 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.