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 |
|---|---|---|---|---|
| Jun 26, 2026 | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D... | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component... | Class II | Galt Medical Corporation |
| Jun 17, 2026 | Ventriculostomy Kit, REF: 46154 | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular... | Class II | Medtronic Neurosurgery |
| Jun 15, 2026 | L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x ... | Catheters, indicated for short/long-term peripheral access to central venous system for the admin... | Class II | Argon Medical Devices, Inc |
| Jun 15, 2026 | L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 | Catheters, indicated for short/long-term peripheral access to central venous system for the admin... | Class II | Argon Medical Devices, Inc |
| Jun 10, 2026 | Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilatera... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 8, 2026 | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, | A product error defect may cause incorrect bracket placement. | Class II | Klowen Braces |
| Jun 1, 2026 | Bone Marrow Tray, REF: CB0033TL; CB0355TLA | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF... | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Arterial Line Kit 20ga x 6, REF: 400115A | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | General Biospy Tray, REF: GUTS1000 | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Apr 28, 2026 | SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: ... | A single lot of expired syringes were distributed due to a distribution system control failure. | Class II | Mentor Texas LP |
| Feb 23, 2026 | Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 | Surgical light assembly may not adequate support the weight of the ceiling cover. | Class II | Stryker Communications |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 16, 2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Mod... | Due to packaging discrepancy with incorrect product size mixed up. | Class II | Encore Medical, LP |
| Feb 16, 2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Mod... | Due to packaging discrepancy with incorrect product size mixed up. | Class II | Encore Medical, LP |
| Feb 1, 2026 | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 | Heart valves were released and distributed before all required testing was complete, so it cannot... | Class II | On-X Life Technologies, Inc. |
| Jan 15, 2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Mo... | Knee and Humeral socket implants contain incorrect labeling. | Class II | Encore Medical, LP |
| Jan 15, 2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUM... | Knee and Humeral socket implants contain incorrect labeling. | Class II | Encore Medical, LP |
| Jan 15, 2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCK... | Knee and Humeral socket implants contain incorrect labeling. | Class II | Encore Medical, LP |
| Jan 5, 2026 | EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H... | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... | Class II | Encore Medical, LP |
| Jan 5, 2026 | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... | Class II | Encore Medical, LP |
| Nov 24, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Ophthalmic procedure packs may have incomplete seals affecting sterility. | Class I | Alcon Research LLC |
| Nov 13, 2025 | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immun... | Class II | Abbott Laboratories |
| Nov 3, 2025 | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PT... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System M... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Oct 6, 2025 | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... | Class II | Abbott Medical |
| Oct 6, 2025 | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... | Class II | Abbott Medical |
| Sep 30, 2025 | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Potential for a weak seal in some units resulting in compromise in sterility. | Class II | Alcon Research LLC |
| Sep 19, 2025 | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation S... | Polyaxial screws do not meet performance standards. | Class II | Orthofix U.S. LLC |
| Sep 17, 2025 | Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS2... | Instructions for use for a foot plating system is being updated to remove the second option of re... | Class II | CPM Medical Consultants, LLC. |
| Sep 15, 2025 | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: ... | XXX | Class II | Alcon Research LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies 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.