Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 12, 2018 | Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk... | Dental varnish has the possibility of having an unpleasant and off flavor. | Class II | Ultradent Products, Inc. |
| Jul 10, 2018 | djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S... | The retaining ring on the neck trials has a potential to fail interoperatively. | Class II | Encore Medical, LP |
| Jul 9, 2018 | Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product U... | INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expi... | Class II | INO therapeutics LLC/dba ikaria |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Ti... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flare... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Fl... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 3, 2018 | Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jul 3, 2018 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip AR... | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter.... | Class II | Arrow International Inc |
| Jul 3, 2018 | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jun 29, 2018 | Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... | An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could... | Class II | Luminex Corporation |
| Jun 29, 2018 | Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B P... | Packages labeled as containing 110mm rods may contain 100mm rods. | Class II | Back 2 Basics Direct LLC |
| Jun 28, 2018 | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes... | Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than... | Class II | Envoy Medical Corporation |
| Jun 27, 2018 | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device i... | Genicon is providing updated IFU labeling to users to provide clarity on how to use the device fo... | Class II | Genicon, Inc. |
| Jun 25, 2018 | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and... | The device accessories were not labeled with appropriate latex warning. | Class II | DJO, LLC |
| Jun 22, 2018 | Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial B... | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... | Class II | Smiths Medical ASD Inc. |
| Jun 22, 2018 | Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: ... | Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for u... | Class III | Clarity Diagnostics Llc |
| Jun 22, 2018 | Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial B... | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... | Class II | Smiths Medical ASD Inc. |
| Jun 21, 2018 | Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KOD... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential ... | Class II | DePuy Orthopaedics, Inc. |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skul... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pi... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 20, 2018 | Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO... | Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it sh... | Class II | Espiner Medical Ltd |
| Jun 19, 2018 | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108... | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver | Class II | Vascular Technology, Inc. |
| Jun 19, 2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ... | Mislabeled hook pouch included a transport/storage label rather than the product label containin... | Class II | Nico Corp. |
| Jun 18, 2018 | Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmi... | Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the ... | Class II | Beaver Visitec |
| Jun 15, 2018 | Endoscopic Cleaning Brush, single use, sold in kits and labeled as the follow... | There is potential risk of brush detachment during cleaning. If brush detachment is not identifi... | Class II | Medline Industries Inc |
| Jun 12, 2018 | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep... | Incorrect use-by date on the device registration/patient file labels. | Class II | Inspire Medical Systems Inc. |
| Jun 11, 2018 | MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pedia... | The product may be packaged with the incorrect length of feeding tube as labeled. | Class II | Canadian Hospital Specialties |
| Jun 11, 2018 | Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm | SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. | Class II | Edwards Lifesciences, LLC |
| Jun 8, 2018 | Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coa... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Pro... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coat... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Pr... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Prod... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 6, 2018 | Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the fol... | GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclea... | Class II | GE Medical Systems, LLC |
| Jun 5, 2018 | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... | Distribution of unapproved product labeling | Class III | Tosoh Bioscience Inc |
| Jun 4, 2018 | Leica Microsystems products labeled as the following: Leica M320 Microscope S... | Possible failure of screws which hold the gas spring fixation bracket in place. Due to this fail... | Class II | Leica Microsystems, Inc. |
| Jun 4, 2018 | EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofu... | Mislabeled product | Class III | Richard-Allan Scientific Company |
| Jun 4, 2018 | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is i... | The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorr... | Class II | CryoLife, Inc. |
| May 30, 2018 | FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL ... | Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufactu... | Class II | Baxter Healthcare Corporation |
| May 29, 2018 | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Pl... | Cap may be mislabeled with incorrect part number, although the correct part number is on the main... | Class II | Implant Direct Sybron Manufacturing, LLC |
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.