Browse Device Recalls
816 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 816 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 816 FDA device recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 5, 2018 | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during ... | Class II | CTL Medical Corporation |
| 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 26, 2018 | Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP... | A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide ... | Class II | Encore Medical, Lp |
| May 23, 2018 | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 23, 2018 | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 23, 2018 | Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing... | This email is to provide notification that, due to a software bug that has been corrected, the Ra... | Class II | Ortho Kinematics, Inc |
| May 16, 2018 | The,K -ASSAY HP assay is intended for the quantitative determination of hum... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | C3 is an in vitro diagnostic assay for the quantitative determination of C3 i... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Transferrin is an in vitro diagnostic assay for the quantitative determinatio... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Apolipoprotein B is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Immunoglobulin G is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Immunoglobulin A is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determ... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | Immunoglobulin M is an in vitro diagnostic assay for the quantitative determi... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 16, 2018 | C4 is an in vitro diagnostic assay for the quantitative determination of C4 i... | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... | Class II | Abbott Laboratories, Inc |
| May 14, 2018 | Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis co... | After receipt of a product complaint for the labeling, it was determined that this device does no... | Class II | Encore Medical, Lp |
| May 8, 2018 | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... | Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu... | Class II | Luminex Corporation |
| May 3, 2018 | ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROC... | Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... | Class II | Joerns Healthcare |
| May 3, 2018 | P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP36... | Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... | Class II | Joerns Healthcare |
| May 2, 2018 | 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilat... | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| May 2, 2018 | TVS LPA, Catalog #: DIL-059-00 | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| May 2, 2018 | 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog... | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| May 2, 2018 | 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) ... | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| May 2, 2018 | Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; ... | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| May 2, 2018 | Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-... | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| May 2, 2018 | Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| May 2, 2018 | 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05... | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... | Class II | Galt Medical Corporation |
| Apr 6, 2018 | Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Pa... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Num... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on labe... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Pa... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on ... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Pa... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Le... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx On... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Par... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Apr 6, 2018 | Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx ... | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... | Class II | Orthofix, Inc |
| Mar 27, 2018 | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo... | Class II | Trilliant Surgical Ltd. |
| Mar 27, 2018 | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo... | Class II | Trilliant Surgical Ltd. |
| Mar 9, 2018 | Proclaim DRG Implantable Pulse Generator, Model Number 3664 | The firm received complaints of error messages that occurred during routine impedance checks on P... | Class II | St. Jude Medical, 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.