Browse Device Recalls
797 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 797 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 797 FDA device recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Feb 27, 2018 | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a... | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended... | Class III | Helena Laboratories, Corp. |
| Feb 23, 2018 | ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w... | Class II | Orthofix, Inc |
| Feb 23, 2018 | ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w... | Class II | Orthofix, Inc |
| Feb 13, 2018 | RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (... | All patient serum samples yield a weakly positive test result. | Class II | Stanbio Laboratory, LP |
| Feb 8, 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The... | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outl... | Class II | Stanbio Laboratory, LP |
| Jan 30, 2018 | AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 8... | Broken or missing screws and retaining clips. This may be due to screw tolerance and material st... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000... | The device could have a missing spanner nut and snap ring which could potentially result in the e... | Class II | Stryker Communications |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 29, 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 8... | It was discovered during a surgery that the design of the radius at the base of the pegs of the A... | Class II | Encore Medical, Lp |
| Jan 26, 2018 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... | The mounts on the monitor may have an insufficient (missing or incomplete) weld. | Class II | Stryker Communications |
| Jan 24, 2018 | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 | Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 program... | Class II | LivaNova USA Inc |
| Jan 12, 2018 | Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a c... | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... | Class II | Alcon Research, LTD. |
| Jan 12, 2018 | Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a c... | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... | Class II | Alcon Research, LTD. |
| Dec 28, 2017 | NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Epimed International |
| Dec 28, 2017 | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Epimed International |
| Dec 12, 2017 | EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Q... | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... | Class II | Encore Medical, Lp |
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.