Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | Class IV New Era medical laser device | The firm failed to comply with the applicable standards regarding Electronic Product Radiation Co... | Class II | Inova Lasers LLC |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 -... | Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human ser... | Class II | Beckman Coulter Inc. |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 28, 2020 | Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 ... | An internal component was assembled in the incorrect orientation, which may lead to the tulip hea... | Class II | Medicrea International |
| Jan 28, 2020 | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed... | When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file r... | Class II | Qiagen Sciences LLC |
| Jan 28, 2020 | Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B360045... | An internal component was assembled in the incorrect orientation, which may lead to the tulip hea... | Class II | Medicrea International |
| Jan 28, 2020 | JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usa... | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dow... | Class II | Smith & Nephew, Inc. |
| Jan 28, 2020 | McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Lar... | Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles ... | Class II | Medtronic, PLC |
| Jan 28, 2020 | JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usa... | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dow... | Class II | Smith & Nephew, Inc. |
| Jan 28, 2020 | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an ... | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstru... | Class II | Breas Medical, Inc. |
| Jan 27, 2020 | Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices ar... | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The uppe... | Class II | Exactech, Inc. |
| Jan 27, 2020 | fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans A... | FridaBaby has been made aware through customer reports that the product is being used outside of ... | Class II | Fridababy LLC |
| Jan 24, 2020 | PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units... | The recall has been initiated due to potential for overheating or a fire hazard associated with ... | Class II | bioMerieux, Inc. |
| Jan 24, 2020 | ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 ... | Potential exists for one or more axes of the robotic stand to become blocked by their safety brak... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 24, 2020 | LN 3R70-01; software version 2.6.2 and earlier. The software is used with th... | Abbott has identified potential performance issues for the Alinity ci -series Software version 2.... | Class II | Abbott Gmbh & Co. KG |
| Jan 23, 2020 | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an ... | A software issue was identified which could result in user or patient injury, or may adversely im... | Class II | Ra Medical Systems, Inc. |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 22, 2020 | FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 008153810200... | There is an increased risk of false positive Proteus results when using the Film Array Blood Cult... | Class II | BioFire Diagnostics, LLC |
| Jan 22, 2020 | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. S... | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... | Class II | Braemar Manufacturing, LLC |
| Jan 22, 2020 | Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... | Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jan 22, 2020 | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. S... | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... | Class II | Braemar Manufacturing, LLC |
| Jan 22, 2020 | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36... | Past updates to programmers and transmitters may lead some implantable cardioverter defibrillator... | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Jan 22, 2020 | FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020... | There is an increased risk of false positive Proteus results when using the Film Array Blood Cult... | Class II | BioFire Diagnostics, LLC |
| Jan 21, 2020 | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... | The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... | Class II | Medline Industries Inc |
| Jan 21, 2020 | COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes,... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, ... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Pr... | The firm is removing the product from the market after discussions with the FDA due to lack of 51... | Class II | Polymer Technology Systems, Inc. |
| Jan 21, 2020 | COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimens... | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions sys... | Class II | Hologic, Inc. |
| Jan 21, 2020 | Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... | The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... | Class II | Medline Industries Inc |
| Jan 21, 2020 | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimen... | When excessive amounts of urine spills on the rack transport track and reaches the electrical co... | Class II | Sysmex America, Inc. |
| Jan 20, 2020 | FlipCutter III Drill | There is potential for the blister tray to be cracked causing the sterile barrier to be compromis... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| Jan 20, 2020 | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2... | Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling t... | Class II | Carolina Liquid Chemistries Corp |
| Jan 19, 2020 | Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and t... | Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay p... | Class II | EHOB, Inc. |
| Jan 17, 2020 | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... | Class II | Kentec Medical, Inc |
| Jan 17, 2020 | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... | Class II | Kentec Medical, Inc |
| Jan 17, 2020 | SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot... | The action is being taken due to an increase in complaints relating to the lower buccal tube slid... | Class II | Ormco/Sybronendo |
| Jan 17, 2020 | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... | Class II | Kentec Medical, Inc |
| Jan 17, 2020 | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... | Class II | Kentec Medical, Inc |
| Jan 17, 2020 | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... | Class II | Kentec Medical, Inc |
| Jan 17, 2020 | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, trans... | Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier ... | Class II | COVIDIEN 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.