Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 8, 2016 | Radial Artery Catheterization Kit with Sharps Safety Features Permits access... | Shipping carton labeling error. | Class II | Arrow International Inc |
| Aug 2, 2016 | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett... | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. | Class III | Alere San Diego, Inc. |
| Jul 29, 2016 | ROSA BRAIN 3.0.0 | Non-conforming product label. | Class II | Zimmer Biomet, Inc. |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
| Jul 26, 2016 | Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two s... | The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone c... | Class II | Encore Medical, Lp |
| Jul 25, 2016 | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled con... | Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tu... | Class II | Terumo Cardiovascular Systems Corp |
| Jul 21, 2016 | FPS 35mm x 3.5 mm non-locking screw | Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. | Class II | Ortho Solutions Inc |
| Jul 21, 2016 | Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, ... | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "position... | Class II | Integra LifeSciences Corp. |
| Jul 18, 2016 | MACH Cranial Treon. The software application is sent in CD format with an IFU... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | MACH AxiEM Cranial Treon. The software application is sent in CD format with ... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | Synergy Spine. The software application is sent in CD format with an IFU, wra... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | Fusion ENT Application. The software application is sent in CD format with an... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... | Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Th... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jul 18, 2016 | Synergy Cranial S7. The software application is sent in CD format with an IFU... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | 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.